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WIZMED sources is data from the FDA, Dailymed, Medicaid data and other data sources and uses calculations to attempt to align datasets. The data feeds may run night, weekly and/or quarterly depending on data source. WIZMED nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any party's use, or the results of such use, of any part of the database or files.

FDA Drug NDCs / Labels

85

Labels

NDA Filings Heparin Sodium , lorlatinib , Dalteparin Sodium , palbociclib , glasdegib , sildenafil citrate , Sunitinib malate , Doxorubicin Hydrochloride , azithromycin dihydrate , PREGABALIN , desvenlafaxine succinate , crisaborole , penicillin G benzathine and penicillin G procaine , neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone , Celecoxib , Metronidazole , verapamil hydrochloride , conjugated estrogens and medroxyprogesterone acetate , talazoparib , amlodipine besylate , amlodipine besylate and atorvastatin calcium , Fosphenytoin Sodium , dofetilide , atorvastatin calcium , gabapentin , methsuximide , ethionamide , penicillin G benzathine , levothyroxine sodium , neomycin sulfate, polymyxin B sulfate, and hydrocortisone acetate , spironolactone , disopyramide phosphate , estrogens, conjugated , Bosutinib monohydrate , fesoterodine fumarate , Meropenem , varenicline tartrate , tofacitinib , Phenelzine Sulfate , quinapril hydrochloride , PANTOPRAZOLE SODIUM , TAZOBACTAM SODIUM and PIPERACILLIN SODIUM , liothyronine sodium , metaxalone , benzonatate , doxycycline calcium , SIROLIMUS , ramipril , diphenoxylate hydrochloride and atropine sulfate , nafarelin acetate , nifedipine , piroxicam , CRIZOTINIB , quinapril hydrochloride and hydrochlorothiazide , nitroglycerin , gemfibrozil , TIGECYCLINE , silver sulfadiazine , oxaprozin , misoprostol , conjugated estrogens , axitinib , prazosin hydrochloride , VENLAFAXINE HYDROCHLORIDE , conjugated estrogens/bazedoxifene , eplerenone , echothiophate iodide , Ethosuximide , temsirolimus , Diclofenac Epolamine , spironolactone and hydrochlorothiazide , diclofenac sodium and misoprostol , dacomitinib , doxycycline hyclate , doxycycline , trimethobenzamide hydrochloride , hydroxyzine pamoate , tafamidis meglumine , tafamidis , Phenytoin , quinupristin and dalfopristin

Authorized Generic Drugs romidepsin

ANDAs (Approved New Drug Applications) Extended Phenytoin Sodium , Ethosuximide , methimazole , Phenytoin , esterified estrogens , penicillin g procaine , AMPICILLIN SODIUM; SULBACTAM SODIUM

Unapproved Drugs azithromycin dihydrate

BLA rituximab-pvvr , Taliglucerase alfa , filgrastim-aafi , epoetin alfa-epbx , Coral Snake (Micrurus Fulvius) Immune Globulin Antivenin (Equine) , bevacizumab-bvzr , inotuzumab ozogamicin , gemtuzumab ozogamicin , infliximab-dyyb , trastuzumab

private labels NovaPlus Premier Intalere Northstar Civica BluePoint Schien (HF or GI)
Vertically Integrated (estimated) doxorub, heparin, neomyci, hydroxy,

FDA Approved Drug Filings

41

Active
FDA Drugs Approvals Returned: DISOPYRAMIDE PHOSPHATE , NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE , PIROXICAM , METRONIDAZOLE , PAROMOMYCIN SULFATE , PALBOCICLIB , GEMFIBROZIL , PREGABALIN , PRAZOSIN HYDROCHLORIDE , POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE , THIOTHIXENE , AMPICILLIN/AMPICILLIN TRIHYDRATE , NIFEDIPINE , DOXEPIN HYDROCHLORIDE , ZALEPLON , TALAZOPARIB TOSYLATE , TROLEANDOMYCIN , OXYTETRACYCLINE HYDROCHLORIDE , BENZONATATE , DOFETILIDE , DOXYLAMINE SUCCINATE , OXAMNIQUINE , DOXYCYCLINE HYCLATE , HYDROXYZINE PAMOATE , AZITHROMYCIN , THIOTHIXENE HYDROCHLORIDE , TIOCONAZOLE , PENICILLIN G POTASSIUM , PENICILLIN V POTASSIUM , AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE , FLUCONAZOLE , BACAMPICILLIN HYDROCHLORIDE , DOXYCYCLINE , BACITRACIN , IRINOTECAN HYDROCHLORIDE , ALPROSTADIL , CEFOPERAZONE SODIUM , HYDROCORTISONE ACETATE , DOCETAXEL , EPIRUBICIN HYDROCHLORIDE , BENZQUINAMIDE HYDROCHLORIDE , METRONIDAZOLE HYDROCHLORIDE , DALTEPARIN SODIUM , HEPARIN SODIUM , MEROPENEM , PLICAMYCIN , PENICILLIN G PROCAINE , PREDNISOLONE ACETATE , STREPTOMYCIN SULFATE , LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE , PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE , TETRACYCLINE HYDROCHLORIDE , SPECTINOMYCIN HYDROCHLORIDE , ALATROFLOXACIN MESYLATE , AMPICILLIN SODIUM; SULBACTAM SODIUM , VIOMYCIN SULFATE , HYDROXYZINE HYDROCHLORIDE , OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE , HYDROCORTISONE , HYDROCORTAMATE HYDROCHLORIDE , NICOTINE , NAFARELIN ACETATE , HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE , ZIPRASIDONE HYDROCHLORIDE , DOXYCYCLINE CALCIUM , OXYTETRACYCLINE CALCIUM , DICLOFENAC SODIUM; MISOPROSTOL , VERAPAMIL HYDROCHLORIDE , GLIPIZIDE , FESOTERODINE FUMARATE , TOFACITINIB CITRATE , QUINAPRIL HYDROCHLORIDE , HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE , HYDROCHLOROTHIAZIDE; SPIRONOLACTONE , SPIRONOLACTONE , RAMIPRIL , MISOPROSTOL , OXYPHENCYCLIMINE HYDROCHLORIDE , GLASDEGIB MALEATE , OXAPROZIN , OXAPROZIN POTASSIUM , CHLORPROPAMIDE , BENZTHIAZIDE , CARBENICILLIN INDANYL SODIUM , LITHIUM CARBONATE , LORLATINIB , RESCINNAMINE , NEOMYCIN SULFATE , ERYTHROMYCIN STEARATE , POLYTHIAZIDE , POLYTHIAZIDE; RESERPINE , TROGLITAZONE , PREDNISOLONE , OXYTETRACYCLINE , TROVAFLOXACIN MESYLATE , DACOMITINIB , ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE

Active Approvals / Active Suppliers: PFIZER , PFIZER INC , PFIZER PHARMS

Active Pharmaceutical Ingredients

34>

Active
Companies with Active, Active Pharmaceutical Ingredients PFIZER INC , PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC , PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC , PHARMACIA AND UPJOHN SUB PFIZER INC

Active Pharmaceutical Ingredients Returned from the Search ACTIVATED CALICHEAMICIN DERIVATIVE , ALPHAMETHYL EPOXIDE , CABERGOLINE USP , HEPARIN SODIUM USP , PRASTERONE ACETATE , 16A-HYDROXYPREDNISOLONE , CLINDAMYCIN PHOSPHATE USP, KALAMAZOO , DEXAMETHASONE ACETATE USP ANHYDROUS MICRONIZED , DEXAMETHASONE SODIUM PHOSPHATE USP , DEXAMETHASONE USP MICRONIZED , DINOPROST TROMETHAMINE , DINOPROSTONE USP , GLIPIZIDE USP , HYDROCORTISONE MICRONIZED AND NON-MICRONIZED , HYDROXYPROGESTERONE CAPROATE USP , LINCOMYCIN HYDROCHLORIDE USP , MEDROXYPROGESTERONE ACETATE USP KALAMAZOO , MEGESTROL ACETATE USP , NOVOBIOCIN SODIUM , PROGESTERONE MICRONIZED AND CRYSTALS , PROGESTERONE USP , TESTOSTERONE CYPIONATE USP , TESTOSTERONE PROPIONATE , BETAMETHYL EPOXIDE , DOXORUBICIN HYDROCHLORIDE , ESTRADIOL CYPIONATE USP , ESTRAMUSTINE PHOSPHATE SODIUM , HYDROCORTISONE ACETATE USP, MICRO & NON-MICRO , METHYLPREDNISOLONE ACETATE USP , NEOMYCIN SULFATE USP , TESTOSTERONE UNDECANOATE , EPOPROSTENOL SODIUM (U-53,217A) , METHYLPREDNISOLONE USP KALAMAZOO , TESTOSTERONE, USP

Tentative FDA Drug Approvals

1

Tentative Approvals
PFIZER INC - ZOLEDRONIC ACID - 4MG/5ML - INJECTABLE;INJECTION

Shared Drug Filings

39

Filings

FDA Drug Shortages

19

Total
Currently in Shortage 10
Drug Shortage Resolved 4
Drug to be Discontinued 5

Pharma Drug Patents

44

Patents
PFIZER INC patent for CAMPTOSAR ( IRINOTECAN HYDROCHLORIDE) for U-449: USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER WHERE THE DOSE OF LEUCOVORIN IS AT LEAST 200MG PER SQUARE METER with EXPIRY of 2020-04-28

PFIZER patent for VIZIMPRO ( DACOMITINIB) for U-1403: FIRST-LINE TREATMENT OF METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST with EXPIRY of 2025-05-05

KING PFIZER patent for ALTACE ( RAMIPRIL) for U-871: METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH with EXPIRY of 2020-08-30

PFIZER patent for TOVIAZ ( FESOTERODINE FUMARATE) for U-913: TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY with EXPIRY of 2027-06-07

PFIZER patent for TOVIAZ ( FESOTERODINE FUMARATE) for U-913: TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY with EXPIRY of 2022-07-03

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for U-247: TREATMENT OF RHEUMATOID ARTHRITIS with EXPIRY of 2020-12-08

PFIZER patent for TROXYCA ER ( NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE) for U-1508: MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED with EXPIRY of 2025-07-03

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for U-2437: TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BREAST CANCER SUSCEPTIBILITY GENE (BRCA)-MUTATED (GBRCAM) HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER with EXPIRY of 2029-07-27

PFIZER patent for IBRANCE ( PALBOCICLIB) for U-1998: TREATING HR-POS., HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER WITH PALBOCICLIB IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE BASED THERAPY IN POSTMENOPAUSAL WOMEN OR FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY with EXPIRY of 2023-01-16

PFIZER patent for IBRANCE ( PALBOCICLIB) for U-2515: PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY with EXPIRY of 2023-01-16

PFIZER patent for LYRICA CR ( PREGABALIN) for U-2137: TREATMENT OF POSTHERPETIC NEURALGIA with EXPIRY of 2026-11-02

PFIZER patent for LYRICA CR ( PREGABALIN) for U-2136: TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY with EXPIRY of 2026-11-02

PFIZER patent for LYRICA CR ( PREGABALIN) for U-2137: TREATMENT OF POSTHERPETIC NEURALGIA with EXPIRY of 2026-11-02

PFIZER patent for LYRICA CR ( PREGABALIN) for U-2136: TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY with EXPIRY of 2026-11-02

PFIZER INC patent for CAMPTOSAR ( IRINOTECAN HYDROCHLORIDE) for U-606: USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER with EXPIRY of 2020-05-01

PFIZER patent for TOVIAZ ( FESOTERODINE FUMARATE) for U-913: TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY with EXPIRY of 2027-06-07

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for U-2322: TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC) with EXPIRY of 2020-12-08

PFIZER patent for LORBRENA ( LORLATINIB) for U-2633: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER, PROGRESSED ON: CRIZOTINIB + AT LEAST 1 OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB, OR CERITINIB AS FIRST ALK INHIBITOR FOR METASTATIC DISEASE. with EXPIRY of 2036-07-27

PFIZER patent for DAURISMO ( GLASDEGIB MALEATE) for : with EXPIRY of 2028-06-29

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2020-12-08

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2023-03-25

PFIZER patent for LYRICA CR ( PREGABALIN) for : with EXPIRY of 2026-11-02

PFIZER patent for IBRANCE ( PALBOCICLIB) for : with EXPIRY of 2023-01-16

PFIZER patent for TROXYCA ER ( NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE) for : with EXPIRY of 2027-12-12

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for : with EXPIRY of 2029-10-19

PFIZER patent for IBRANCE ( PALBOCICLIB) for : with EXPIRY of 2023-01-16

PFIZER patent for VIZIMPRO ( DACOMITINIB) for : with EXPIRY of 2028-08-26

PFIZER patent for IBRANCE ( PALBOCICLIB) for : with EXPIRY of 2034-02-08

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2020-12-08

PFIZER patent for TOVIAZ ( FESOTERODINE FUMARATE) for : with EXPIRY of 2027-06-07

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for : with EXPIRY of 2031-10-20

PFIZER patent for LORBRENA ( LORLATINIB) for : with EXPIRY of 2033-03-05

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for : with EXPIRY of 2031-10-20

PFIZER INC patent for GEODON ( ZIPRASIDONE HYDROCHLORIDE) for : with EXPIRY of 2020-05-18

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2020-12-08

PFIZER patent for TALZENNA ( TALAZOPARIB TOSYLATE) for : with EXPIRY of 2029-07-27

PFIZER patent for DAURISMO ( GLASDEGIB MALEATE) for : with EXPIRY of 2036-04-13

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2034-03-14

PFIZER patent for IBRANCE ( PALBOCICLIB) for : with EXPIRY of 2023-01-16

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2025-12-08

PFIZER patent for XELJANZ XR ( TOFACITINIB CITRATE) for : with EXPIRY of 2034-03-14

PFIZER patent for DAURISMO ( GLASDEGIB MALEATE) for : with EXPIRY of 2031-01-30

PFIZER INC patent for CAMPTOSAR ( IRINOTECAN HYDROCHLORIDE) for : with EXPIRY of 2020-10-28

PFIZER INC patent for CAMPTOSAR ( IRINOTECAN HYDROCHLORIDE) for : with EXPIRY of 2020-11-01

PFIZER patent for LYRICA CR ( PREGABALIN) for : with EXPIRY of 2027-05-02

PFIZER patent for LYRICA CR ( PREGABALIN) for : with EXPIRY of 2027-05-02

PFIZER patent for LYRICA CR ( PREGABALIN) for : with EXPIRY of 2027-05-02


FDA Drug Exclusivity

92

Exclusivities
PFIZER DALTEPARIN SODIUM - FRAGMIN - 18,000IU/0.72ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 15,000IU/0.6ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 12,500IU/0.5ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 7,500 IU/0.75ML - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 95,000IU/9.5ML (10,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 95,000IU/3.8ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 7,500IU/0.3ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 10,000IU/ML (10,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 5,000IU/0.2ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 10,000IU/0.4ML (25,000IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER DALTEPARIN SODIUM - FRAGMIN - 2,500IU/0.2ML (12,500IU/ML) - NPP:NEW PATIENT POPULATION -2022-05-16
PFIZER PREGABALIN - LYRICA - 300MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 300MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 225MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 225MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 200MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 200MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 150MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 150MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 100MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 100MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 75MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 75MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 50MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 50MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 25MG - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 25MG - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER PREGABALIN - LYRICA - 20MG/ML - NPP:NEW PATIENT POPULATION -2021-05-03
PFIZER PREGABALIN - LYRICA - 20MG/ML - NPP:NEW PATIENT POPULATION -2022-05-23
PFIZER TOFACITINIB CITRATE - XELJANZ XR - EQ 11MG BASE - I-761:NEW INDICATION (SEE INDIVIDUAL REFERENCES) -2020-12-14
PFIZER TALAZOPARIB TOSYLATE - TALZENNA - EQ 0.25MG BASE - NCE:NEW CHEMICAL ENTITY -2023-10-16
PFIZER TALAZOPARIB TOSYLATE - TALZENNA - EQ 1MG BASE - NCE:NEW CHEMICAL ENTITY -2023-10-16
PFIZER PALBOCICLIB - IBRANCE - 75MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 125MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 100MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PREGABALIN - LYRICA CR - 82.5MG - NP:NEW PRODUCT -2020-10-11
PFIZER PREGABALIN - LYRICA CR - 165MG - NP:NEW PRODUCT -2020-10-11
PFIZER PREGABALIN - LYRICA CR - 330MG - NP:NEW PRODUCT -2020-10-11
PFIZER DACOMITINIB - VIZIMPRO - 45MG - ODE-206:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 45MG - NCE:NEW CHEMICAL ENTITY -2023-09-27
PFIZER DACOMITINIB - VIZIMPRO - 45MG - ODE-213:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 15MG - ODE-206:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 15MG - NCE:NEW CHEMICAL ENTITY -2023-09-27
PFIZER DACOMITINIB - VIZIMPRO - 15MG - ODE-213:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 30MG - ODE-206:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER DACOMITINIB - VIZIMPRO - 30MG - NCE:NEW CHEMICAL ENTITY -2023-09-27
PFIZER DACOMITINIB - VIZIMPRO - 30MG - ODE-213:ORPHAN DRUG EXCLUSIVITY -2025-09-27
PFIZER LORLATINIB - LORBRENA - 25MG - NCE:NEW CHEMICAL ENTITY -2023-11-02
PFIZER LORLATINIB - LORBRENA - 25MG - ODE-218:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 25MG - ODE-217:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 25MG - ODE-219:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 100MG - NCE:NEW CHEMICAL ENTITY -2023-11-02
PFIZER LORLATINIB - LORBRENA - 100MG - ODE-218:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 100MG - ODE-219:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER LORLATINIB - LORBRENA - 100MG - ODE-217:ORPHAN DRUG EXCLUSIVITY -2025-11-02
PFIZER PALBOCICLIB - IBRANCE - 125MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 75MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER PALBOCICLIB - IBRANCE - 100MG - NCE:NEW CHEMICAL ENTITY -2020-02-03
PFIZER GLASDEGIB MALEATE - DAURISMO - EQ 100MG BASE - NCE:NEW CHEMICAL ENTITY -2023-11-21
PFIZER GLASDEGIB MALEATE - DAURISMO - EQ 100MG BASE - ODE-224:ORPHAN DRUG EXCLUSIVITY -2025-11-21
PFIZER GLASDEGIB MALEATE - DAURISMO - EQ 25MG BASE - NCE:NEW CHEMICAL ENTITY -2023-11-21
PFIZER GLASDEGIB MALEATE - DAURISMO - EQ 25MG BASE - ODE-224:ORPHAN DRUG EXCLUSIVITY -2025-11-21
PFIZER PREGABALIN - LYRICA - 300MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 225MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 200MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 150MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 100MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 75MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 50MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 25MG - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 300MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 225MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 200MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 150MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 100MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 75MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 50MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 25MG - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 300MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 225MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 200MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 150MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 100MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 75MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 50MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 25MG - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA - 20MG/ML - PED:PEDIATRIC EXCLUSIVITY -2022-11-23
PFIZER PREGABALIN - LYRICA - 20MG/ML - PED:PEDIATRIC EXCLUSIVITY -2021-11-03
PFIZER PREGABALIN - LYRICA - 20MG/ML - PED:PEDIATRIC EXCLUSIVITY -2020-06-22
PFIZER PREGABALIN - LYRICA CR - 330MG - PED:PEDIATRIC EXCLUSIVITY -2021-04-11
PFIZER PREGABALIN - LYRICA CR - 165MG - PED:PEDIATRIC EXCLUSIVITY -2021-04-11
PFIZER PREGABALIN - LYRICA CR - 82.5MG - PED:PEDIATRIC EXCLUSIVITY -2021-04-11

Federal Supply Schedule Pricing

2

Vendors on FSS
Companies on Federal Supply Schedule Pfizer Inc. , Pfizer, Inc.

Pharmaceutical Drugs on Federal Supply Schedule RITUXIMAB-PVVR 10MG/ML INJ,SOLN , ALPROSTADIL 10MCG/VIL IMPULSE INJ,SYSTEM , ALPROSTADIL 20MCG/VIL IMPLUSE INJ,SYSTEM , ALPROSTADIL 20MCG/VIL INJ , ALPROSTADIL 40MCG/VIL INJ , ALPROSTADIL 500MCG/ML INJ , AMPICILLIN NA/SULBACTAM NA 1.5GM/VIL INJ , AMPICILLIN NA/SULBACTAM NA 15GM/VIL INJ , AMPICILLIN NA/SULBACTAM NA 3GM/VIL INJ , ANIDULAFUNGIN 100MG/VIL INJ , ANIDULAFUNGIN 50MG/VIL INJ , ANTI-THYMOCYTE GLOBULIN 50MG/ML INJ,PF , ANTIHEMOPHILIC FACTOR,RECOMBINANT 1000UNT/VIL INJ , ANTIHEMOPHILIC FACTOR,RECOMBINANT 2000UNT/VIL INJ , ANTIHEMOPHILIC FACTOR,RECOMBINANT 3000UNT/VIL INJ , ANTIHEMOPHILIC FACTOR,RECOMBINANT,PLASMA/ALBUMIN FREE 1000IU/VIL , ANTIHEMOPHILIC FACTOR,RECOMBINANT,PLASMA/ALBUMIN FREE 2000IU/VIL , ANTIHEMOPHILIC FACTOR,RECOMBINANT,PLASMA/ALBUMIN FREE 250IU/VIL , ANTIHEMOPHILIC FACTOR,RECOMBINANT,PLASMA/ALBUMIN FREE 500IU/VIL , ANTIVENIN,MICRURUS FULVIUS INJ , ARGININE HCL 30GM/300ML INJ , ATROPINE SO4 0.025MG/DIPHENOXYLATE HCL 2.5MG TAB , AXITINIB 1MG TAB , AXTINIB 5MG TAB , AZITHROMYCIN 100MG/5ML SUSP,ORAL , AZITHROMYCIN 1GM/PKT PWDR,ORAL , AZITHROMYCIN 200MG/5ML SUSP,ORAL , AZITHROMYCIN 250MG TAB , AZITHROMYCIN 250MG TAB,PKT,6 , AZITHROMYCIN 500MG TAB , AZITHROMYCIN 500MG TAB,PKT,3 , AZITHROMYCIN DIHYDRATE 500MG/VIL INJ , B-TRACIN 400UNT/HC 1%/N-MYCIN 5MG/POLYMYX 5000UNT/GM OINT,TOP , BACITRACIN 50000UNT/VIL INJ , BAZEDOXIFENE 20MG/ESTROGENS,CONJUGATED 0.45MG TAB , BENZONATATE 100MG CAP , BEVACIZUMAB-BVZR 25MG/ML INJ,16ML , BEVACIZUMAB-BVZR 25MG/ML INJ,4ML , BEVACIZUMAB-BVZR 25MG/ML, 16ML INJ , BEVACIZUMAB-BVZR 25MG/ML, 4ML INJ , BOSUTINIB 100MG TAB , BOSUTINIB 400MG TAB , BOSUTINIB 500MG TAB , CARBOPROST 250MCG/TROMETHAMINE 83MCG/ML INJ , CLINDAMYCIN HCL 150MG CAP , CLINDAMYCIN HCL 300MG CAP , CLINDAMYCIN HCL 75MG CAP , CLINDAMYCIN PHOSPHATE 100MG SUPP,VAG , CLINDAMYCIN PO4 1% GEL,TOP , CLINDAMYCIN PO4 1% LOTION , CLINDAMYCIN PO4 150MG/ML INJ , CLINDAMYCIN PO4 150MG/ML INJ,VIL,2ML , CLINDAMYCIN PO4 2% CREAM,VAG , COLESTIPOL GRANULES , COLESTIPOL HCL 1GM TAB , COLESTIPOL HCL 5GM/PKT GRANULES , COLESTIPOL HCL 7.5GM/PKT GRANULES,FLAVORED , COLESTIPOL HCL GRANULES,FLAVORED , CRISABOROLE 2% OINT,TOP , CRIZ0TINIB 200MG CAP , CRIZ0TINIB 250MG CAP , DACOMITINIB 15MG TAB , DACOMITINIB 30MG TAB , DACOMITINIB 45MG TAB , DALFOPRISTIN 350MG/QUINUPRISTIN 150MG/VIL INJ , DALTEPARIN NA 10000UNT/1ML SYRINGE , DALTEPARIN NA 12500UNT/0.5ML SYRINGE , DALTEPARIN NA 15000UNT/0.6ML SYRINGE , DALTEPARIN NA 18000UNT/0.72ML SYRINGE , DALTEPARIN NA 25000UNT/3.8ML SYRINGE , DALTEPARIN NA 2500UNT/0.2ML SYRINGE , DALTEPARIN NA 5000UNT/0.2ML SYRINGE , DALTEPARIN NA 7500UNT/0.3ML SYRINGE , DESVENLAFAXINE (EQV-PRISTIQ) 25MG TAB,SA , DESVENLAFAXINE 100MG TAB,SA , DESVENLAFAXINE 50MG TAB,SA , DESVENLAFAXINE 50MG TAB,SA, , DEXRAZOXANE HCL 250MG/VIL INJ , DICLOFENAC EPOLAMINE 1.3% PATCH , DICLOFENAC NA 50MG/MISOPROSTOL 200MCG TAB , DICLOFENAC NA 75MG/MISOPROSTOL 200MCG TAB , DINOPROSTONE 0.5MG/3GM APPLICATOR,VAG , DINOPROSTONE 20MG SUPP,VAG , DISOPYRAMIDE PO4 100MG CAP , DISOPYRAMIDE PO4 100MG CAP,SA , DISOPYRAMIDE PO4 150MG CAP , DISOPYRAMIDE PO4 150MG CAP,SA , DOFETILIDE 125MCG CAP , DOFETILIDE 125MCG CAP,UD , DOFETILIDE 250MCG CAP , DOFETILIDE 250MCG CAP,UD , DOFETILIDE 500MCG CAP , DOFETILIDE 500MCG CAP,UD , DOXORUBICIN HCL 2MG/ML VIL,INJ , DOXYCYCLINE CA 50MG/5ML SUSP , DOXYCYCLINE HYCLATE 100MG CAP , DOXYCYCLINE MONOHYDRATE 25MG/5ML LIQUID , ECHOTHIOPHATE IODIDE 0.125% SOLN,OPH , EPIRUBICIN HCL 2MG/ML INJ , EPOETIN ALFA-EPBX 10000UNIT/ML INJ,SOLN , EPOETIN ALFA-EPBX 2000UNIT/ML INJ,SOLN , EPOETIN ALFA-EPBX 3000UNIT/ML INJ,SOLN , EPOETIN ALFA-EPBX 40000UNIT/ML INJ,SOLN , EPOETIN ALFA-EPBX 4000UNIT/ML INJ,SOLN , ESTRADIOL 2MG RING,VAG , ESTRADIOL CYPIONATE 5MG/ML INJ (IN OIL) , ESTRAMUSTINE PO4 SODIUM 140MG CAP , ESTROGENS,CONJUGATED 0.3MG TAB , ESTROGENS,CONJUGATED 0.45MG TAB , ESTROGENS,CONJUGATED 0.625MG TAB , ESTROGENS,CONJUGATED 0.625MG/GM CREAM,VAG , ESTROGENS,CONJUGATED 0.9MG TAB , ESTROGENS,CONJUGATED 1.25MG TAB , ESTROGENS,CONJUGATED 5MG/ML INJ,SOLN , ETHIONAMIDE 250MG TAB , ETHOSUXIMIDE 250MG CAP , ETHOSUXIMIDE 250MG/5ML SYRUP , EXEMESTANE 25MG TAB , FACTOR IX,RECOMBINANT 1000 UNT/VIL INJ , FACTOR IX,RECOMBINANT 250 UNT/VIL INJ , FACTOR IX,RECOMBINANT 500 UNT/VIL INJ , FACTOR IX/RECOMBINANT 2000 UNT/VIL INJ , FACTOR IX/RECOMBINANT 3000 UNT/VIL INJ , FESOTERODINE FUMARATE 4MG TAB,SA , FESOTERODINE FUMARATE 8MG TAB,SA , FILGRASTIM-AAFI 600MCG/ML (PF) INJ,SYRINGE,0.5ML , FILGRASTIM-AAFI 600MCG/ML (PF) INJ,SYRINGE,0.8ML , FLUCONAZOLE 100MG TAB , FLUCONAZOLE 10MG/ML SUSP,ORAL , FLUCONAZOLE 150MG TAB , FLUCONAZOLE 200MG TAB , FLUCONAZOLE 40MG/ML SUSP,ORAL , FLUCONAZOLE 50MG TAB , FOSPHENYTOIN NA 100MG-PE/2ML INJ , FOSPHENYTOIN NA 50MG-PE/10ML INJ , GELATIN,ABSORBABLE PWDR , GELATIN,ABSORBABLE SPONGE,DENTAL SIZE 4 , GELATIN,ABSORBABLE SPONGE,SZ 100 , GELATIN,ABSORBABLE SPONGE,SZ 12,7MM , GELATIN,ABSORBABLE SPONGE,SZ 200 , GELATIN,ABSORBABLE SPONGE,SZ 50 , GEMFIBROZIL 600MG TAB , GEMTUZUMAB OZOGAMICIN 5MG/VIL INJ , GLASDEGIB 100MG TAB , GLASDEGIB 25MG TAB , GLIPIZIDE 10MG TAB , GLIPIZIDE 10MG TAB,SA , GLIPIZIDE 2.5MG TAB,SA , GLIPIZIDE 5MG TAB , GLIPIZIDE 5MG TAB,SA , GLOBULIN,IMMUNE (IGG)HIPP (SQ) 16.5% INJ , GLOBULIN,IMMUNE (IV) 10% INJ , GLYBURIDE 1.5MG TAB , GLYBURIDE 3MG TAB , GLYBURIDE 6MG TAB , HC 0.5%/N-MYCIN 3.5MG/POLYMYX 10000UNIT/GM CREAM,TOP , HEPARIN NA (PORK) 5000UNT/ML INJ , HEPARIN NA 1000UNT/ML (PF) INJ , HEPARIN NA 1000UNT/ML INJ , HYDROCHLOROTHIAZIDE 12.5MG/QUINAPRIL HCL 10MG TAB , HYDROCHLOROTHIAZIDE 12.5MG/QUINAPRIL HCL 20MG TAB , HYDROCHLOROTHIAZIDE 25MG/QUINAPRIL HCL 20MG TAB , HYDROCHLOROTHIAZIDE 25MG/SPIRONOLACTONE 25MG TAB , HYDROCHLOROTHIAZIDE 50MG/SPIRONOLACTONE 50MG TAB , HYDROCORTISONE 10MG TAB , HYDROCORTISONE 20MG TAB , HYDROCORTISONE 5MG TAB , HYDROCORTISONE NA SUCCINATE 1000MG/VIL INJ,SOLN , HYDROCORTISONE NA SUCCINATE 100MG/VIL INJ,SOLN , HYDROCORTISONE NA SUCCINATE 125MG/ML INJ,SOLN , HYDROCORTISONE NA SUCCINATE 500MG/VIL INJ,SOLN , HYDROCORTISONE NA SUCCINATE 50MG/ML INJ,SOLN , HYDROXYZINE PAMOATE 25MG CAP , HYDROXYZINE PAMOATE 50MG CAP , IBUTILIDE FUMARATE 0.1MG/ML INJ,SOLN , IDARUBICIN HCL 1MG/ML (PF) INJ,SOLN , INFLIXIMAB 100MG/20MLVIL (PF) INJ , INOTUZUMAB OZOGAMICIN 0.9MG/VIL INJ , IRINOTECAN HCL 20MG/ML INJ,SOLN , LEVOTHYROXINE NA 100MCG TAB , LEVOTHYROXINE NA 112MCG TAB , LEVOTHYROXINE NA 125MCG TAB , LEVOTHYROXINE NA 137MCG TAB , LEVOTHYROXINE NA 150MCG TAB , LEVOTHYROXINE NA 175MCG TAB , LEVOTHYROXINE NA 200MCG TAB , LEVOTHYROXINE NA 25MCG TAB , LEVOTHYROXINE NA 50MCG TAB , LEVOTHYROXINE NA 75MCG TAB , LEVOTHYROXINE NA 88MCG TAB , LINCOMYCIN HCL 300MG/ML INJ , LINEZOLID 100MG/5ML SUSP,ORAL , LINEZOLID 2MG/ML INJ,BAG,100ML , LINEZOLID 2MG/ML INJ,BAG,300ML , LINEZOLID 600MG TAB , LINEZOLID 600MG TAB,UD , LIOTHYRONINE NA 25MCG TAB , LIOTHYRONINE NA 50MCG TAB , LIOTHYRONINE NA 5MCG TAB , LORLATINIB 100MG TAB , LORLATINIB 25MG TAB , MEDROXYPROGESTERONE ACETATE 104MG/0.65ML INJ,SUSP,SYRINGE , MEDROXYPROGESTERONE ACETATE 10MG TAB , MEDROXYPROGESTERONE ACETATE 150MG/ML INJ,SUSP , MEDROXYPROGESTERONE ACETATE 150MG/ML INJ,SUSP,SYRINGE,1ML , MEDROXYPROGESTERONE ACETATE 2.5MG TAB , MEDROXYPROGESTERONE ACETATE 400MG/ML INJ,SUSP , MEDROXYPROGESTERONE ACETATE 5MG TAB , MEROPENEM 1GM/VIL INJ , MEROPENEM 500MG/VIL INJ , METAXALONE 800MG TAB , METHSUXIMIDE 300MG CAP , METHYLPREDNISOLONE 16MG TAB , METHYLPREDNISOLONE 2MG TAB , METHYLPREDNISOLONE 32MG TAB , METHYLPREDNISOLONE 4MG TAB , METHYLPREDNISOLONE 4MG TAB DOSEPAK,21 , METHYLPREDNISOLONE 8MG TAB , METHYLPREDNISOLONE ACETATE 20MG/ML INJ,SUSP , METHYLPREDNISOLONE ACETATE 40MG/ML INJ,SUSP , METHYLPREDNISOLONE ACETATE 80MG/ML INJ,SUSP , METHYLPREDNISOLONE NA SUCCINATE 1000MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 125MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 2000MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 40MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 500MG/VIL INJ , METRONIDAZOLE 250MG TAB , METRONIDAZOLE 375MG CAP , METRONIDAZOLE 500MG TAB , MIGLITOL 100MG TAB , MIGLITOL 25MG TAB , MIGLITOL 50MG TAB , MISOPROSTOL 100MCG TAB , MISOPROSTOL 200MCG TAB , NAFARELIN ACETATE 2MG/ML SOLN,NASAL , NEISSERIA MENINGITIDIS VACCINE (TRUMENBA) INJ,0.5ML,SYR , NICOTINE 10MG/CARTRIDGE INHL,ORAL,168/KIT , NICOTINE 10MG/ML SOLN,NASAL SPRAY , NIFEDIPINE (PROCARDIA XL) 30MG SA TAB , NIFEDIPINE (PROCARDIA XL) 60MG SA TAB , NIFEDIPINE (PROCARDIA XL) 90MG SA TAB , NIFEDIPINE 10MG CAP , OXAPROZIN 600MG TAB , PALBOCICLIB 100MG CAP,ORAL , PALBOCICLIB 100MG TAB,ORAL , PALBOCICLIB 125MG CAP,ORAL , PALBOCICLIB 125MG TAB,ORAL , PALBOCICLIB 75MG CAP,ORAL , PALBOCICLIB 75MG TAB,ORAL , PANTOPRAZOLE NA 20MG TAB,EC , PANTOPRAZOLE NA 40MG TAB,EC , PANTOPRAZOLE NA 40MG/PKT PWDR,ORAL , PANTOPRAZOLE NA 40MG/VIL INJ , PEGVISOMANT PROTEIN 10MG/VIL INJ , PEGVISOMANT PROTEIN 15MG/VIL INJ , PEGVISOMANT PROTEIN 20MG/VIL INJ , PEGVISOMANT PROTEIN 25MG/VIL INJ , PEGVISOMANT PROTEIN 30MG/VIL INJ , PEN G BENZATHINE 300000UNT/PEN G PROCAINE 300000UNT/ML INJ,SUSP , PEN G BENZATHINE 450000UNT/PEN G PROCAINE 150000UNT/ML INJ,SUSP , PENICILLIN G BENZATHINE 600000UNT/ML INJ,SUSP , PENICILLIN G K 20MILLION UNT/VIL INJ , PENICILLIN G K 5MILLION UNT/VIL INJ , PENICILLIN G PROCAINE 600000UNT/ML INJ,SUSP , PHENELZINE SO4 15MG TAB , PIPERACILLIN NA 2GM/TAZOBACTAM NA 0.25GM/50ML INJ,BAG,50ML , PIPERACILLIN NA 3GM/TAZOBACTAM 0.375GM/50ML INJ,BAG,50ML , PIPERACILLIN NA 4GM/TAZOBACTAM NA 0.5GM/100ML INJ,BAG,100ML , PIROXICAM 10MG CAP , PIROXICAM 20MG CAP , PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE , PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE/0.5ML , PRAZOSIN HCL 1MG CAP , PRAZOSIN HCL 2MG CAP , PRAZOSIN HCL 5MG CAP , PREMPHASE COMBO BLIS PAK,14+14 , PREMPRO 0.3MG/1.5MG TAB,28 PACK , PREMPRO 0.45MG/1.5MG TAB,28 PACK , PREMPRO 0.625MG/2.5MG TAB,28 PACK , PREMPRO 0.625MG/5MG TAB,28 PACK , QUINAPRIL HCL 10MG TAB , QUINAPRIL HCL 20MG TAB , QUINAPRIL HCL 40MG TAB , QUINAPRIL HCL 5MG TAB , RAMIPRIL 1.25MG CAP , RAMIPRIL 10MG CAP , RAMIPRIL 2.5MG CAP , RAMIPRIL 5MG CAP , RIFABUTIN 150MG CAP , RITUXIMAB-PVVR 10MG/ML INJ,SOLN , SILVER SULFADIAZINE 1% CREAM,TOP , SIROLIMUS 0.5MG PK 10X10, TAB , SIROLIMUS 0.5MG TAB , SIROLIMUS 1MG TAB , SIROLIMUS 1MG TAB,UD , SIROLIMUS 1MG/ML SOLN,ORAL , SIROLIMUS 2MG TAB , SOMATROPIN 0.2MG/VIL INJ,MINIQUICK , SOMATROPIN 0.4MG/VIL INJ,MINIQUICK , SOMATROPIN 0.6MG/VIL INJ,MINIQUICK , SOMATROPIN 0.8MG/VIL INJ,MINIQUICK , SOMATROPIN 1.2MG/VIL INJ,MINIQUICK , SOMATROPIN 1.4MG/VIL INJ,MINIQUICK , SOMATROPIN 1.6MG/VIL INJ,MINIQUICK , SOMATROPIN 1.8MG/VIL INJ,MINIQUICK , SOMATROPIN 12MG/VIL INJ , SOMATROPIN 1MG/VIL INJ,MINIQUICK , SOMATROPIN 2MG/VIL INJ,MINIQUICK , SOMATROPIN 5MG/VIL INJ,INTRA-MIX , SPIRONOLACTONE 100MG TAB , SPIRONOLACTONE 25MG TAB , SPIRONOLACTONE 50MG TAB , SULFASALAZINE 500MG TAB , SULFASALAZINE 500MG TAB,EC , SUNITINIB MALATE 12.5MG CAP,ORAL , SUNITINIB MALATE 25MG CAP,ORAL , SUNITINIB MALATE 37.5MG CAP,ORAL , SUNITINIB MALATE 50MG CAP,ORAL , TAFAMIDIS 61MG CAPSULE , TAFAMIDIS MEGLUMINE 20MG CAP,ORAL , TALAZOPARIB 0.25MG CAP,ORAL , TALAZOPARIB 1MG CAP,ORAL , TALIGLUCERASE ALFA 200 UNIT/VIL INJ , TEMSIROLIMUS 25MG/ML INJ,VIAL , TESTOSTERONE CYPIONATE 100MG/ML INJ (IN OIL) , TESTOSTERONE CYPIONATE 200MG/ML INJ (IN OIL) , THROMBIN 20000UNT/VIL PWDR,TOP , THROMBIN 5,000UNIT/VIL (BOVINE) SPRAY,TOP KIT , THROMBIN 5000UNIT/VIL (BOVINE) SPRAY, TOP KIT , THROMBIN 5000UNT/VIL PWDR,TOP , THROMBIN 5000UNT/VIL SOLN,NASAL,KIT W/SYRINGE , TIGECYCLINE 50MG/VIL INJ , TOFACITINIB 11MG 24HR TAB,SA , TOFACITINIB CITRATE 10MG TAB , TOFACITINIB CITRATE 22MG 24HR TAB,SA , TOFACITINIB CITRATE 5MG TAB , TRANEXAMIC ACID 100MG/ML INJ, VI,10ML , TRANEXAMIC ACID 100MG/ML INJ,AMP,10ML , TRASTUZUMAB-QYYP 420MG/VIAL INJ , TRIAZOLAM 0.25MG TAB , TRIMETHOBENZAMIDE HCL 300MG CAP , VARENICLINE TARTRATE 0.5MG TAB , VARENICLINE TARTRATE 1MG TAB , VARENICLINE TARTRATE 1MG TAB,56 , VARENICLINE TARTRATE TAB STARTER PACK,53 , VERAPAMIL HCL 120MG TAB,SA , VERAPAMIL HCL 180MG TAB,SA , VERAPAMIL HCL 240MG TAB,SA , VORICONAZOLE 200MG TAB , VORICONAZOLE 200MG/VIL INJ , VORICONAZOLE 40MG/ML SUSP,ORAL , VORICONAZOLE 50MG TAB

FDA Production Site Inspection Outcomes since 2019

8 / 0

2019 / 2020 Inspections
No Action Indicated:
Pfizer Boulder - Boulder - CO - US - 2019-12-20
Pfizer Inc - Chesterfield - MO - US - 2019-08-20
Pfizer Clinical Research Unit - New Haven - CT - US - 2019-06-14
Pfizer Clinical Research Unit, Hopital Erasme - Anderlecht - - BE - 2019-04-12

Voluntary Action Indicated:
Pfizer Manufacturing Deutschland GmbH - Freiburg im Breisgau - - DE - 2019-03-08
Pfizer Ireland Pharmaceuticals - Newbridge - - IE - 2019-09-27
Pfizer Pharmaceuticals LLC - Barceloneta - PR - US - 2019-12-20

Official Action Indicated:
Pfizer Healthcare India Private Limited - Visakhapatnam - - IN - 2019-09-06

Recent FDA Recalls (Abridged)

23

Recent Recalls
Pfizer Inc - Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24 - Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
7,686 100-count bottles, 20191002

Pfizer Inc - Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
701 cartons (25 vials per carton), 20190410

Pfizer Inc - Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
8,878 cartons (25 vials per carton), 20190410

Pfizer Inc - Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
8,320 cartons (25 vials per carton), 20190410

Pfizer Inc - Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray). - Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
38,676 trays, 20200219

Pfizer Inc - Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03 - Lack of Assurance of Sterility
185,700 vials, 20190918

Pfizer Inc - Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017. - Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
100277 tablets, 20190522

Pfizer Inc - RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017. - Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
a) 20,117 cartons; b) 2,502 cartons, 20190904

Pfizer Inc - 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02 - Presence of Particulate Matter; glass particulates
283,400 vials, 20190410

Pfizer Inc - Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 mg/200 mL, 200 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-02, Barcode (01)00304092776028. - Lack of Assurance of Sterility: Bags have the potential to leak.
58200 bags, 20190724

Pfizer Inc - Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
67 cartons (25 vials per carton), 20190410

Pfizer Inc - Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
820 cartons (25 vials per carton), 20190410

Pfizer Inc - Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83 - Presence of Particulate Matter: particulate matter identified after reconstitution.
94320 units, 20200617

Pfizer Inc - Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01 - Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point
500 cartons (25 vials per carton), 20190410

Pfizer Inc - 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13 - Lack of Assurance of Sterility: Bag has the potential to leak.
17832 bags, 20191016

Pfizer Inc - Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20 mg/100 mL, 100 mL bag, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2776-23, Barcode (01)00304092776233. - Lack of Assurance of Sterility: Bags have the potential to leak.
280340 bags, 20190724

Pfizer Inc - Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12 - Failed Dissolution Specifications
544400 packages, 20200701

Pfizer Inc - Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30. - Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
141 bottles, 20200219

Pfizer Inc - Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30. - Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
128 bottles, 20200219

Pfizer Inc - Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01 - Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
24,714 vials, 20200311

Pfizer Inc - Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12 - Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
19,144 vials, 20200812

Pfizer Inc - ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2 - Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
7,824 100-count bottles, 20191002

Pfizer Inc - 25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10 - Labeling: Incorrect or Missing Lot and/or expiration date.
77,100 syringes, 20191218

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