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FDA Drug NDCs / Labels

162

Labels
NDA Filings Hydromorphone hydrochloride , Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride , Calcium Acetate , MAGNESIUM SULFATE HEPTAHYDRATE , Fish oil , LIDOCAINE HYDROCHLORIDE , PROPOFOL , TOBRAMYCIN SULFATE , BUPIVACAINE HYDROCHLORIDE , LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE , HEPARIN SODIUM , Atropine Sulfate , MOXIFLOXACIN HYDROCHLORIDE , Morphine Sulfate , PENTAMIDINE ISETHIONATE , Neostigmine Methylsulfate , Anticoagulant Sodium Citrate Solution , INDOMETHACIN , Dextrose, Soybean oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid and Tyrosine , Levothyroxine Sodium , Tigecycline , ROPIVACAINE HYDROCHLORIDE , Caspofungin Acetate , BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE , CHLOROPROCAINE HYDROCHLORIDE , Argatroban , Bortezomib , Smoflipid , iron sucrose , Daptomycin , LEVOTHYROXINE SODIUM ANHYDROUS , Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic , LINEZOLID , FUROSEMIDE , Glucagon , clevidipine , Fulvestrant , sucroferric oxyhydroxide , OXYTOCIN , Calcium Gluconate , ACETAMINOPHEN , PALONOSETRON HYDROCHLORIDE

Authorized Generic Drugs enoxaparin sodium , Calcium Acetate

ANDAs (Approved New Drug Applications) GENTAMICIN SULFATE , GEMCITABINE , CISPLATIN , MAGNESIUM SULFATE HEPTAHYDRATE , FLUOROURACIL , DACARBAZINE , MITOXANTRONE HYDROCHLORIDE , KETOROLAC TROMETHAMINE , DEXAMETHASONE SODIUM PHOSPHATE , CEFAZOLIN SODIUM , METHYLPREDNISOLONE SODIUM SUCCINATE , VINBLASTINE SULFATE , CLINDAMYCIN PHOSPHATE , Vancomycin Hydrochloride , Piperacillin Sodium and Tazobactam Sodium , ACYCLOVIR SODIUM , NAFCILLIN SODIUM , Cefepime , Imipenem and Cilastatin Sodium , POLYMYXIN B SULFATE , OCTREOTIDE ACETATE , AZITHROMYCIN MONOHYDRATE , AZTREONAM , BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE , Enoxaparin Sodium , HYDRALAZINE HYDROCHLORIDE , SODIUM CHLORIDE , CHLOROTHIAZIDE SODIUM , DIPHENHYDRAMINE HYDROCHLORIDE , ACETYLCYSTEINE , Paclitaxel , Ertapenem Sodium , Dicyclomine Hydrochloride , BENZTROPINE MESYLATE , ampicillin sodium , Lactulose , THIAMINE HYDROCHLORIDE , DOXYCYCLINE , CLADRIBINE , PROGESTERONE , PIPERACILLIN SODIUM,TAZOBACTAM SODIUM , TOBRAMYCIN SULFATE , Cefoxitin Sodium , LEVETIRACETAM , BUPIVACAINE HYDROCHLORIDE , VALPROATE SODIUM , Meropenem , AMIODARONE HYDROCHLORIDE , Palonosetron , FAMOTIDINE , Azacitidine , Methocarbamol , POTASSIUM CHLORIDE , Piperacillin and Tazobactam , Heparin Sodium , CHLORAMPHENICOL SODIUM SUCCINATE , CYANOCOBALAMIN , METHOTREXATE SODIUM , SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE , LIDOCAINE HYDROCHLORIDE , NAFCILLIN , LEVOFLOXACIN , Daptomycin , CEFOTETAN DISODIUM , MIDAZOLAM HYDROCHLORIDE , CISATRACURIUM BESYLATE , Dexmedetomidine Hydrochloride , Bivalirudin , Glycopyrrolate , Leucovorin calcium , ADENOSINE , Linezolid , Remifentanil Hydrochloride , MESNA , Dextrose Monohydrate , Metoclopramide Hydrochloride , ONDANSETRON HYDROCHLORIDE , SODIUM ACETATE , Folic Acid , FLUDARABINE PHOSPHATE , PROTAMINE SULFATE , MEPIVACAINE HYDROCHLORIDE , GRANISETRON HYDROCHLORIDE , COLISTIMETHATE SODIUM , HALOPERIDOL LACTATE , clofarabine , DEFEROXAMINE MESYLATE , TERBUTALINE SULFATE , Micafungin Sodium , TOPOTECAN HYDROCHLORIDE , Zoledronic Acid , ETOPOSIDE , CYTARABINE , FLOXURIDINE , GENTAMICIN , FLUPHENAZINE DECANOATE , GANCICLOVIR SODIUM , HALOPERIDOL DECANOATE , ESMOLOL HYDROCHLORIDE , Decitabine , DOXORUBICIN HYDROCHLORIDE , FOSAPREPITANT , MANNITOL , BLEOMYCIN SULFATE , IFOSFAMIDE , Ceftriaxone , Dimenhydrinate , METOPROLOL TARTRATE , Fentanyl Citrate , Amikacin Sulfate , WATER , RIFAMPIN , ROCURONIUM BROMIDE , MILRINONE LACTATE , Oxaliplatin , Phenylephrine Hydrochloride , IRINOTECAN HYDROCHLORIDE , Sumatriptan Succinate , FOSPHENYTOIN SODIUM , Tranexamic Acid , Arsenic Trioxide , Melphalan Hydrochloride , Vecuronium Bromide , Busulfan , PYRIDOXINE HYDROCHLORIDE , BACITRACIN , CAFFEINE CITRATE , FLUMAZENIL , PROPRANOLOL HYDROCHLORIDE , CARBOPLATIN , FLUPHENAZINE HYDROCHLORIDE , CLONIDINE HYDROCHLORIDE , DAUNORUBICIN HYDROCHLORIDE , DEXTROSE; POTASSIUM CHLORIDE , DEXTROSE; SODIUM CHLORIDE , DIPYRIDAMOLE , EPIRUBICIN HYDROCHLORIDE , FLUCONAZOLE , IDARUBICIN HYDROCHLORIDE , OXACILLIN SODIUM , PAMIDRONATE DISODIUM , PIPERACILLIN SODIUM; TAZOBACTAM SODIUM , POTASSIUM CHLORIDE; SODIUM CHLORIDE , VINORELBINE TARTRATE , ICATIBANT ACETATE , EPHEDRINE SULFATE , ANASTROZOLE

Unapproved Drugs hydroxyprogesterone caproate , SODIUM CHLORIDE , WATER , SODIUM GLYCOLATE , SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE , POTASSIUM PHOSPHATE, MONOBASIC and POTASSIUM PHOSPHATE, DIBASIC , PROPOFOL

BLA Chorionic Gonadotropin

private labels NovaPlus Premier Intalere Northstar Civica BluePoint Schien (HF or GI)
Vertically Integrated (estimated) lactulo, paclita, irinote, oxalipl, ceftria, anastro, gemcita, ampicil, busulfa, decitab, piperac, ropivac, cefepim,

FDA Approved Drug Filings

175

Active approvals
Active Approvals / Active Suppliers: FRESENIUS MEDCL , FRESENIUS KABI USA , FRESENIUS , FRESENIUS KABI , VIFOR FRESENIUS

FDA Drugs Approvals Returned: CALCIUM ACETATE , VANCOMYCIN HYDROCHLORIDE , AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN , FISH OIL TRIGLYCERIDES , FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL , PENTAMIDINE ISETHIONATE , ACYCLOVIR SODIUM , ADENOSINE , AMIKACIN SULFATE , AMIODARONE HYDROCHLORIDE , ARGATROBAN , ARSENIC TRIOXIDE , MORPHINE SULFATE , AZITHROMYCIN , AZTREONAM , BACITRACIN , SODIUM CHLORIDE , BENZTROPINE MESYLATE , BLEOMYCIN SULFATE , CALCITRIOL , CARBOPLATIN , CEFAZOLIN SODIUM , CEFOTAXIME SODIUM , CEFOTETAN DISODIUM , CEFOXITIN SODIUM , CEFTRIAXONE SODIUM , CEFUROXIME SODIUM , CHLORAMPHENICOL SODIUM SUCCINATE , CHLOROTHIAZIDE SODIUM , CIPROFLOXACIN , CISATRACURIUM BESYLATE , CISPLATIN , CLADRIBINE , CLINDAMYCIN PHOSPHATE , CLONIDINE HYDROCHLORIDE , COLISTIMETHATE SODIUM , CYANOCOBALAMIN , CYTARABINE , DACARBAZINE , DAUNORUBICIN HYDROCHLORIDE , DEFEROXAMINE MESYLATE , DEXAMETHASONE SODIUM PHOSPHATE , DEXMEDETOMIDINE HYDROCHLORIDE , DEXTROSE , DEXTROSE; SODIUM CHLORIDE , DEXTROSE; POTASSIUM CHLORIDE , DICYCLOMINE HYDROCHLORIDE , HYDROMORPHONE HYDROCHLORIDE , DIMENHYDRINATE , DIPHENHYDRAMINE HYDROCHLORIDE , PROPOFOL , DIPYRIDAMOLE , DOXORUBICIN HYDROCHLORIDE , DOXYCYCLINE HYCLATE , EPIRUBICIN HYDROCHLORIDE , ESMOLOL HYDROCHLORIDE , ETOPOSIDE , FAMOTIDINE , FENTANYL CITRATE , FLOXURIDINE , FLUCONAZOLE , FLUDARABINE PHOSPHATE , FLUMAZENIL , FLUOROURACIL , FLUPHENAZINE DECANOATE , FLUPHENAZINE HYDROCHLORIDE , FOLIC ACID , FOSPHENYTOIN SODIUM , FUROSEMIDE , GANCICLOVIR SODIUM , GEMCITABINE HYDROCHLORIDE , GENTAMICIN SULFATE , GLYCOPYRROLATE , GRANISETRON HYDROCHLORIDE , HALOPERIDOL LACTATE , HALOPERIDOL DECANOATE , HEPARIN SODIUM , HYDRALAZINE HYDROCHLORIDE , HYDROXYZINE HYDROCHLORIDE , IDARUBICIN HYDROCHLORIDE , IFOSFAMIDE , INDOMETHACIN , SOYBEAN OIL , IOPAMIDOL , IRINOTECAN HYDROCHLORIDE , KANAMYCIN SULFATE , KETOROLAC TROMETHAMINE , CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE , LEUCOVORIN CALCIUM , LEVOFLOXACIN , LIDOCAINE HYDROCHLORIDE , MAGNESIUM SULFATE , MANNITOL , MELPHALAN HYDROCHLORIDE , METARAMINOL BITARTRATE , METHOTREXATE SODIUM , METHYLPREDNISOLONE SODIUM SUCCINATE , METOCLOPRAMIDE HYDROCHLORIDE , METOPROLOL TARTRATE , MIDAZOLAM HYDROCHLORIDE , MILRINONE LACTATE , MITOXANTRONE HYDROCHLORIDE , NAFCILLIN SODIUM , CHLOROPROCAINE HYDROCHLORIDE , OCTREOTIDE ACETATE , ONDANSETRON HYDROCHLORIDE , OXACILLIN SODIUM , OXYTOCIN , PACLITAXEL , PAMIDRONATE DISODIUM , PHENYTOIN SODIUM , PIPERACILLIN SODIUM; TAZOBACTAM SODIUM , MEPIVACAINE HYDROCHLORIDE , POLYMYXIN B SULFATE , POTASSIUM CHLORIDE , POTASSIUM CHLORIDE; SODIUM CHLORIDE , PROGESTERONE , PROPRANOLOL HYDROCHLORIDE , PROTAMINE SULFATE , PYRIDOXINE HYDROCHLORIDE , REMIFENTANIL HYDROCHLORIDE , RIFAMPIN , ROCURONIUM BROMIDE , BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE , BUPIVACAINE HYDROCHLORIDE , SODIUM ACETATE , TERBUTALINE SULFATE , THIAMINE HYDROCHLORIDE , THIOTEPA , TOBRAMYCIN SULFATE , TOPOTECAN HYDROCHLORIDE , TRANEXAMIC ACID , VALPROATE SODIUM , VINBLASTINE SULFATE , VINCRISTINE SULFATE , VINORELBINE TARTRATE , EPINEPHRINE; LIDOCAINE HYDROCHLORIDE , ACETYLCYSTEINE , BIVALIRUDIN , LEVETIRACETAM , MESNA , MICAFUNGIN SODIUM , OXALIPLATIN , PALONOSETRON HYDROCHLORIDE , ZOLEDRONIC ACID , ICATIBANT ACETATE , SUMATRIPTAN SUCCINATE , STERILE WATER FOR INJECTION , GLUCAGON HYDROCHLORIDE , BORTEZOMIB , CASPOFUNGIN ACETATE , DAPTOMYCIN , FOSAPREPITANT DIMEGLUMINE , LEVOTHYROXINE SODIUM , TIGECYCLINE , METHOCARBAMOL , ROPIVACAINE HYDROCHLORIDE , FULVESTRANT , CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE , CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE , ACETAMINOPHEN , CAFFEINE CITRATE , CALCIUM GLUCONATE , EPHEDRINE SULFATE , LINEZOLID , MOXIFLOXACIN HYDROCHLORIDE , NEOSTIGMINE METHYLSULFATE , PHENYLEPHRINE HYDROCHLORIDE , POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC , ATROPINE SULFATE , LACTULOSE , SUCROFERRIC OXYHYDROXIDE , ANASTROZOLE , BICALUTAMIDE , LETROZOLE

Active Pharmaceutical Ingredients

1

Active API Holders
Companies with Active APIs FRESENIUS KA

APIs Returned LACTULOSE SOLUTION USP , LACTULOSE CRYSTALS , PACLITAXEL SEMISYNTHETIC , IRINOTECAN HYDROCHLORIDE TRIHY , OXALIPLATIN , CEFTRIAXONE SODIUM STERILE , BICALUTAMIDE , LACTULOSE CONCENTRATE USP , ANASTROZOLE , BUFFERED CEFTAZIDIME PENTAHYDR , LETROZOLE , GEMCITABINE HYDROCHLORIDE , AMPICILLIN SODIUM STERILE , AMPICILLIN TRIHYDRATE STERILE , BUSULFAN , BUFFERED OXACILLIN SODIUM STER , DOCETAXEL , BUFFERED NAFCILLIN SODIUM STER , AMPICILLIN SODIUM/SULBACTAM SO , BUFFERED PENICILLIN G POTASSIU , DECITABINE , PIPERACILLIN SODIUM/ TAZOBACTA , HETACILLIN POTASSIUM STERILE , ROPIVACAINE HYDROCHLORIDE , BENDAMUSTINE HYDROCHLORIDE , CLOXACILLIN BENZATHINE STERILE , CEFEPIME HYDROCHLORIDE STERILE , CEFEPIME ARGININE STERILE , CARFILZOMIB , AFATINIB DIMALEATE , IBRUTINIB , BELINOSTAT , PENICILLIN G SODIUM STERILE , BUFFERED PENICILLIN G SODIUM S , PLERIXAFOR , ALECTINIB HYDROCHLORIDE , SUGAMMADEX SODIUM

Tentative FDA Drug Approvals

5

Tentative Approvals
FRESENIUS KABI USA - GEMCITABINE HYDROCHLORIDE - EQ 200MG BASE/VIAL - INJECTABLE; INJECTION
FRESENIUS KABI USA - GEMCITABINE HYDROCHLORIDE - EQ 1GM BASE/VIAL - INJECTABLE; INJECTION
FRESENIUS KABI USA - CABAZITAXEL - 20MG/ML - INJECTABLE;INJECTION
FRESENIUS KABI USA - DEXMEDETOMIDINE HYDROCHLORIDE - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) - INJECTABLE;INJECTION
FRESENIUS KABI USA - BENDAMUSTINE HYDROCHLORIDE - 100MG/4ML (25MG/ML) - SOLUTION;IV (INFUSION)

Pharma Drug Patents

35

Patents
FRESENIUS MEDCL patent for PHOSLYRA ( CALCIUM ACETATE) for U-1469: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS with EXPIRY of 2027-07-20

FRESENIUS MEDCL patent for PHOSLYRA ( CALCIUM ACETATE) for U-1469: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS with EXPIRY of 2027-07-20

FRESENIUS KABI USA patent for MORPHINE SULFATE ( MORPHINE SULFATE) for U-43: MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for MORPHINE SULFATE ( MORPHINE SULFATE) for U-55: TREATMENT OF PAIN with EXPIRY of 2034-03-12

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for U-1468: CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS with EXPIRY of 2030-01-23

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for U-1468: CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS with EXPIRY of 2020-06-12

FRESENIUS KABI USA patent for FULVESTRANT ( FULVESTRANT) for U-2540: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN with EXPIRY of 2034-05-17

FRESENIUS KABI USA patent for OMEGAVEN ( FISH OIL TRIGLYCERIDES) for U-2585: TREATMENT OF PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS IN PATIENTS UNDER THE AGE OF 12 with EXPIRY of 2024-11-05

FRESENIUS KABI USA patent for OMEGAVEN ( FISH OIL TRIGLYCERIDES) for U-2367: USE FOR PATIENTS WITH PARENTERAL NUTRITION ASSOCIATED CHOLESTASIS OR PARENTERAL NUTRITION ASSOCIATED LIVER DISEASE with EXPIRY of 2025-07-11

FRESENIUS MEDCL patent for PHOSLYRA ( CALCIUM ACETATE) for U-1469: USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS with EXPIRY of 2030-02-23

FRESENIUS KABI USA patent for FULVESTRANT ( FULVESTRANT) for U-2540: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN with EXPIRY of 2034-02-14

FRESENIUS KABI USA patent for OMEGAVEN ( FISH OIL TRIGLYCERIDES) for U-2366: TREATMENT OF LIVER DISEASE THROUGH NUTRITION FOR PATIENTS UNDER THE AGE OF 12 with EXPIRY of 2025-07-11

FRESENIUS KABI USA patent for FULVESTRANT ( FULVESTRANT) for U-2540: TREATMENT OF HORMONE RECEPTOR POSITIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN with EXPIRY of 2034-02-14

FRESENIUS KABI USA patent for DILAUDID ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2032-04-23

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for : with EXPIRY of 2028-11-13

FRESENIUS KABI USA patent for DILAUDID ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2020-11-09

FRESENIUS KABI USA patent for DIPRIVAN ( PROPOFOL) for : with EXPIRY of 2024-12-01

FRESENIUS KABI USA patent for DILAUDID ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2032-08-29

FRESENIUS KABI USA patent for NAROPIN ( ROPIVACAINE HYDROCHLORIDE) for : with EXPIRY of 2024-05-23

FRESENIUS KABI USA patent for NAROPIN ( ROPIVACAINE HYDROCHLORIDE) for : with EXPIRY of 2025-10-18

FRESENIUS MEDCL patent for PHOSLO GELCAPS ( CALCIUM ACETATE) for : with EXPIRY of 2021-04-03

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2032-08-29

FRESENIUS KABI USA patent for ACETAMINOPHEN ( ACETAMINOPHEN) for : with EXPIRY of 2030-04-19

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2036-12-01

FRESENIUS KABI USA patent for DILAUDID-HP ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2020-11-09

FRESENIUS MEDCL patent for PHOSLO GELCAPS ( CALCIUM ACETATE) for : with EXPIRY of 2021-07-30

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2036-12-01

FRESENIUS KABI USA patent for NAROPIN ( ROPIVACAINE HYDROCHLORIDE) for : with EXPIRY of 2026-11-28

FRESENIUS KABI USA patent for MORPHINE SULFATE ( MORPHINE SULFATE) for : with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for DILAUDID-HP ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2032-04-23

FRESENIUS KABI USA patent for NAROPIN ( ROPIVACAINE HYDROCHLORIDE) for : with EXPIRY of 2023-05-18

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for : with EXPIRY of 2028-11-13

FRESENIUS KABI USA patent for MORPHINE SULFATE ( MORPHINE SULFATE) for : with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for LEVOTHYROXINE SODIUM ( LEVOTHYROXINE SODIUM) for : with EXPIRY of 2032-10-03

FRESENIUS MEDCL patent for PHOSLO ( CALCIUM ACETATE) for : with EXPIRY of 2021-04-03

FRESENIUS KABI USA patent for DILAUDID-HP ( HYDROMORPHONE HYDROCHLORIDE) for : with EXPIRY of 2034-03-12

FRESENIUS KABI USA patent for CASPOFUNGIN ACETATE ( CASPOFUNGIN ACETATE) for : with EXPIRY of 2032-12-21

VIFOR FRESENIUS patent for VELPHORO ( SUCROFERRIC OXYHYDROXIDE) for : with EXPIRY of 2034-11-26

FRESENIUS KABI USA patent for BORTEZOMIB ( BORTEZOMIB) for : with EXPIRY of 2032-11-03

FRESENIUS KABI USA patent for DIPRIVAN ( PROPOFOL) for : with EXPIRY of 2025-06-01


FDA Drug Exclusivity

10

Exclusivities
FRESENIUS KABI USA MICAFUNGIN SODIUM - MICAFUNGIN SODIUM - EQ 100MG BASE/VIAL - PC:PATENT CHALLENGE -2020-11-07
FRESENIUS KABI USA MICAFUNGIN SODIUM - MICAFUNGIN SODIUM - EQ 50MG BASE/VIAL - PC:PATENT CHALLENGE -2020-11-07
FRESENIUS KABI USA FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - SMOFLIPID 20% - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML) - NCE:NEW CHEMICAL ENTITY -2021-07-13
FRESENIUS KABI USA FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - SMOFLIPID 20% - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML) - NCE:NEW CHEMICAL ENTITY -2021-07-13
FRESENIUS KABI USA FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - SMOFLIPID 20% - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML) - NCE:NEW CHEMICAL ENTITY -2021-07-13
FRESENIUS KABI USA FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL - SMOFLIPID 20% - 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML) - NCE:NEW CHEMICAL ENTITY -2021-07-13
FRESENIUS KABI USA FISH OIL TRIGLYCERIDES - OMEGAVEN - 10GM/100ML (0.1GM/ML) - NCE:NEW CHEMICAL ENTITY -2023-07-27
FRESENIUS KABI USA FISH OIL TRIGLYCERIDES - OMEGAVEN - 5GM/50ML (0.1GM/ML) - NCE:NEW CHEMICAL ENTITY -2023-07-27
FRESENIUS KABI USA FISH OIL TRIGLYCERIDES - OMEGAVEN - 10GM/100ML (0.1GM/ML) - ODE-202:ORPHAN DRUG EXCLUSIVITY -2025-07-27
FRESENIUS KABI USA FISH OIL TRIGLYCERIDES - OMEGAVEN - 5GM/50ML (0.1GM/ML) - ODE-202:ORPHAN DRUG EXCLUSIVITY -2025-07-27

Federal Supply Schedule Pricing

2

Vendors on FSS
Companies on Federal Supply Schedule Fresenius USA, Inc. , Fresenius Kabi, LLC

Pharmaceutical Drugs on Federal Supply Schedule CALCIUM ACETATE 667MG/5ML SOL , CALCIUM ACETATE 667MG (CA 169MG) CAP , SUCROFERRIC OXYHYDROXIDE 500MG TAB,CHEW , GENTAMICIN SO4 80MG/VIL INJ , GENTAMICIN SO4 40MG/ML INJ , CHLORAMPHENICOL NA SUCCINATE 1GM/VIL INJ , OXYTOCIN 10UNT/ML INJ , THIAMINE HCL 100MG/ML INJ , MANNITOL 250MG/ML INJ , SODIUM ACETATE 4MEQ/ML (PF) INJ , CYANOCOBALAMIN 1000MCG/ML INJ , CHLOROPROCAINE HCL 2% INJ , HEPARIN NA (PORK) 5000UNT/ML INJ , MAGNESIUM SO4 4MEQ/ML (PF) INJ , SODIUM CHLORIDE 23.4% (PF) INJ,CONC , DOXORUBICIN HCL 2MG/ML INJ , CISPLATIN 50MG/VIL INJ , CISPLATIN 200MG/VIL (PF) INJ , CISPLATIN 100MG/VIL (PF) INJ , ETOPOSIDE 20MG/ML INJ,VIL,5ML , ETOPOSIDE 20MG/ML INJ,VIL,25ML , ETOPOSIDE 20MG/ML INJ,VIL,50ML , MAGNESIUM SO4 4GM/100ML INJ,BAG , MAGNESIUM SO4 2GM/50ML INJ,BAG , MAGNESIUM SO4 40GM/1000ML INJ,BAG , MAGNESIUM SO4 20GM/500ML INJ/BAG , MAGNESIUM SO4 4GM/50ML INJ,BAG , MAGNESIUM SO4 1GM/100ML INJ,BAG , PENTAMIDINE ISETHIONATE 300MG/VIL INJ , FLUOROURACIL 50MG/ML INJ , FLUOROURACIL 100MG/ML INJ , HEPARIN NA 5000 UNT/0.5ML SYRINGE,0.5ML , CYTARABINE 2GM/VIL INJ , METHOTREXATE NA 1GM/VIL INJ , METHOTREXATE NA 250MG/VIL INJ , GEMCITABINE HCL 2GM/VIL INJ , DACARBAZINE 100MG/VIL INJ , DACARBAZINE 200MG/VIL INJ , DOXYCYCLINE HYCLATE 100MG/VIL INJ , MITOXANTRONE HCL 2MG/ML INJ , CLADRIBINE 1MG/ML INJ , IFOSFAMIDE 1GM/VIL INJ , FLOXURIDINE 500MG/VIL INJ , KETOROLAC TROMETHAMINE 15MG/ML INJ , KETOROLAC TROMETHAMINE 30MG/ML INJ , LACTATED RINGER'S INJ , DEXAMETHASONE NA PHOSPHATE 4MG/ML INJ,SOLN , GENTAMICIN SO4 10MG/ML (PF) INJ , WATER FOR INJECTION, STERILE , PYRIDOXINE HCL 100MG/ML INJ , FOLIC ACID 5MG/ML INJ , WATER FOR INJECTION , WATER FOR INJECTION,STERILE,50ML , SODIUM CHLORIDE 0.9% INJ , SODIUM CHLORIDE 120MEQ/30ML VIL, INJ , FLUDARABINE PO4 50MG/VIL INJ , IRINOTECAN HCL 20MG/ML INJ,SOLN , VANCOMYCIN HCL 750MG/VIL INJ , FISH OIL EMULSION 0.1G/ML INJ, 100ML , FISH OIL EMULSION 0.1G/ML INJ, 50ML , LIDOCAINE HCL 20MG/ML (PF) INJ , PROTAMINE SO4 10MG/ML INJ , CHLOROPROCAINE HCL 3% INJ , CEFAZOLIN NA 500MG/VIL INJ , CEFAZOLIN NA 1GM/VIL INJ , CEFAZOLIN NA 10GM/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 40MG/VIL INJ , METHYLPREDNISOLONE NA SUCCINATE 125MG/VIL INJ , MEPIVACAINE HCL 1% INJ , PROGESTERONE 50MG/ML (IN OIL) INJ,SOLN , METHYLPREDNISOLONE NA SUCCINATE 1000MG/VIL INJ , PROPOFOL 10MG/ML INJ,EMULSION , FLUPHENAZINE DECANOATE 25MG/ML INJ , SUMATRIPTAN SUCCINATE 6MG/0.5ML INJ,VIL,0.5ML , HEPARIN NA 1000UNT/ML (PF) INJ , VINBLASTINE SO4 1MG/ML INJ , FUROSEMIDE 10MG/ML INJ , FUROSEMIDE 40MG/5ML INJ , FUROSEMIDE 100MG/10ML INJ , FLUPHENAZINE HCL 2.5MG/ML INJ , ROPIVACAINE HCL 0.2% INJ,AMP,10ML , ROPIVACAINE HCL 20MG/VIL INJ , ROPIVACAINE HCL 0.2% INJ,AMP,20ML , ROPIVACAINE HCL 40MG/20ML INJ , ROPIVACAINE HCL 0.2% INJ,BAG,100ML , ROPIVACAINE HCL 0.2% INJ,BAG,200ML , ROPIVACAINE HCL 0.2% INJ,BTL,200ML , ROPIVACAINE HCL 0.2% INJ,BTL,100ML , ROPIVACAINE HCL 0.5% INJ,AMP,20ML , ROPIVACAINE HCL 100MG/20ML INJ , ROPIVACAINE HCL 0.5% INJ,STERILE-PAK,30ML , ROPIVACAINE HCL 0.5% INJ,VIL,30ML , ROPIVACAINE HCL 0.75% INJ,AMP,20ML , ROPIVACAINE HCL 0.75% INJ,VIL,20ML , ROPIVACAINE HCL 1% INJ,AMP,10ML , ROPIVACAINE HCL 1% INJ,VIL,10ML , ROPIVACAINE HCL 1% INJ,AMP,20ML , ROPIVACAINE HCL 2% INJ,VIL,20ML , MEPIVACAINE HCL 1.5% INJ , MEPIVACAINE HCL 2% INJ , VANCOMYCIN HCL 5GM/VIL INJ , TOBRAMYCIN SO4 1.2GM/VIL INJ , PIPERACILLIN NA 40.5GM/TAZOBACTAM NA 0.25GM/VIL INJ , TOBRAMYCIN SO4 10MG/ML INJ , TOBRAMYCIN SO4 40MG/ML INJ , VANCOMYCIN HCL 10GM/VIL INJ , GANCICLOVIR 500MG/VIL INJ , GRANISETRON HCL 1 MG/ML VIAL , GRANISETRON HCL 1MG/ML INJ,4ML VIL , CILASTATIN NA 500MG/IMIPENEM 500MG/VIL INJ IV , ACYCLOVIR NA 50MG/ML INJ , NAFCILLIN NA 1GM/VIL INJ , NAFCILLIN NA 2GM/VIL INJ , NAFCILLIN NA 10GM/VIL INJ , CEFOXITAN NA 1GM/VIL INJ , CEFOXITIN NA 2GM/VIL INJ , CEFTRIAXONE NA 1GM/VIL INJ , CILASTATIN NA 250MG/IMIPENEM 250MG/VIL INJ IV , RIFAMPIN 600MG/VIL INJ , LEVOFLOXACIN/DEXTROSE 250MG/50ML, INJ,BAG,50ML , LEVOFLOXACIN/DEXTROSE 750MG/150ML,INJ,BAG,150ML , LEVOFLOXACIN/DEXTROSE 500MG/100ML, INJ,BAG,50ML , CASPOFUNGIN ACETATE 50 MG, VIAL , CASPOFUNGIN ACETATE 70 MG, VIAL , CALCIUM GLUCONATE 100MG/ML INJ , DIMENHYDRINATE 50MG/ML INJ , DAPTOMYCIN 500MG/VIL INJ , ONDANSETRON HCL 2MG/ML INJ,SOLN , OCTREOTIDE ACETATE 0.1MG/ML INJ , OCTREOTIDE ACETATE 0.5MG/ML INJ , OCTREOTIDE ACETATE 0.2MG/ML INJ , OCTREOTIDE ACETATE 1MG/ML INJ , CEFOTETAN DISODIUM 1GM/VIL INJ , CEFOTETAN DISODIUM 2GM/VIL INJ , COLISTIMETHATE NA 150MG/VIL INJ , AZITHROMYCIN DIHYDRATE 500MG/VIL INJ , LEVETIRACETAM 500MG/5ML INJ , AZTREONAM 1GM/VIL INJ , AZTREONAM 2GM/VIL INJ , FOSPHENYTOIN NA 50MG-PE/ML INJ , CAFFEINE CITRATE 20MG/ML INJ , MIDAZOLAM HCL 1MG/ML INJ , MIDAZOLAM HCL 5MG/ML INJ , NEOSTIGMINE METHYLSULFATE 0.5MG/ML INJ , NEOSTIGMINE METHYLSULFATE 1MG/ML INJ , CISATRACURIUM BESYLATE 2MG/ML INJ,SOLN , LIDOCAINE HCL 0.5% INJ , CISATRACURIUM BESYLATE 10MG/ML INJ,SOLN , DEXMEDETOMIDINE HCL 100MCG/ML INJ , FLUMAZENIL 0.1MG/ML INJ , ROCURONIUM BR 10MG/ML INJ,5ML VIL , ROCURONIUM BR 10MG/ML INJ,10ML VIL , MORPHINE SO4 10MG/ML INJ , MORPHINE SO4 2MG/ML INJ , MORPHINE SO4 4MG/ML INJ , MORPHINE SO4 5MG/ML INJ , MORPHINE SO4 8MG/ML INJ , BUPIVACAINE HCL 225MG/EPINEPHRINE VIL INJ , BUPIVICAINE HCL 125MG/50ML/EPINEPHRINE VIL INJ , BUPIVACAINE HCL 50MG/10ML W/EPINEPHRINE VIL INJ , BUPIVACAINE HCL 0.5%/EPINEPHRINE 1:200000 INJ , BUPIVACAINE HCL 25MG/50ML VIL INJ , MEROPENEM 1GM/VIL,INJ , BUPIVACAINE HCL 25MG/10ML VIL INJ , BUPIVACAINE HCL 0.25% INJ , BUPIVACAINE HCL 75MG/30ML VIL INJ , BUPIVACAINE HCL 125MG/50ML VIL INJ , BUPIVACAINE HCL 0.5% INJ , BUPIVACAINE HCL 150MG/30ML VIL INJ , BUPIVACAINE HCL 250MG/50ML VIL INJ , BUPIVACAINE HCL 0.25%/EPINEPHRINE 1:200000 INJ , HALOPERIDOL DECANOTE 50MG/ML INJ , HALOPERIDOL DECANOTE 250MG/5ML INJ , HALOPERIDOL DECANOTE 100MG/ML INJ , HALOPERIDOL DECANOTE 500MG/5ML INJ , BUPIVACAINE HCL 75MG/10ML SOLN , BUPIVACAINE HCL 225MG/30ML VIL INJ , HALOPERIDOL 5MG/ML INJ , CHLOROPROCAINE HCL 1% INJ , LIDOCAINE HCL 1%/EPINEPHRINE 1:100000 INJ , LIDOCAINE HCL 1% INJ , LIDOCAINE HCL 2% INJ , LIDOCAINE HCL 2%/EPINEPHRINE 1:100000 INJ , LIDOCAINE HCL 1% (PF) INJ , LIDOCAINE HCL 1%/EPINEPHRINE 1:200000 INJ , LIDOCAINE HCL 1.5% INJ , LIDOCAINE HCL 1.5%/EPINEPHRINE 1:200000 INJ , LIDOCAINE HCL 2%/EPINEPHRINE 1:200000 INJ , LIDOCAINE HCL 0.5% (PF) INJ , LIDOCAINE HCL 1.5% (PF) INJ , VALPROATE NA 100MG/ML INJ , DEXAMETHASONE NA PHOSPHATE 10MG/ML INJ,SOLN , MEROPENEM 500MG/VIL,INJ , ARGATROBAN 100MG/ML INJ,CONC , ENOXAPARIN 80MG/ML INJ , ENOXAPARIN 30MG/ML INJ , ENOXAPARIN 40MG/ML INJ , ENOXAPARIN 150MG/ML INJ,SYRINGE,1ML , ENOXAPARIN 100MG/ML INJ , HEPARIN NA (PORK) 1000UNT/ML INJ , HEPARIN NA 1000UNT/ML INJ , HEPARIN NA 10000UNT/ML INJ , HEPARIN NA 5000UNT/0.5/ML INJ , BIVALIRUDIN 250MG/VIL INJ , TRANEXAMIC ACID 100MG/ML INJ,VIL,10ML , ENOXAPARIN 60MG/ML INJ , ENOXAPARIN 120MG/0.8ML INJ,SYRINGE,0.8ML , GLYCOPYRROLATE 0.2MG/ML INJ , ATROPINE SO4 0.4MG/ML INJ , GLUCAGON 1MG/VIL INJ,EMERGENCY KIT , DAPTOMYCIN 350MG/VIL INJ , GLUCAGON 1MG/VIL INJ , GLUCAGON FOR INJ POWDER 1MG/3ML , DEFEROXAMINE MESYLATE 500MG/VIL INJ , DEFEROXAMINE MESYLATE 2GM/VIL INJ , DEXTROSE 5% INJ,BAG,250ML , PROPRANOLOL HCL 1MG/ML INJ , HYDRALAZINE HCL 20MG/ML INJ , AMIODARONE HCL 50MG/ML INJ,AMP,3ML , AMIODARONE HCL 50MG/ML INJ,9ML , MILRINONE LACTATE 1MG/ML INJ , SODIUM CHLORIDE 0.9% INJ,BAG,50ML , SODIUM CHLORIDE 0.9% INJ,BAG,100ML , SODIUM CHLORIDE 0.9% INJ,BAG,250ML , SODIUM CHLORIDE 0.9% INJ,BAG,500ML , SODIUM CHLORIDE 0.9% INJ,BAG,1000ML , DEXTROSE 5% INJ,BAG,1000ML , DEXTROSE 5% INJ,BAG,50ML , DEXTROSE 5% INJ,BAG,100ML , DEXTROSE 5% INJ,BAG,500ML , SODIUM CHLORIDE 0.45% INJ , LEUCOVORIN CALCIUM (CALCIUM FOLINATE 10MG/ML INJ) , ARSENIC TRIOXIDE 1MG/ML INJ , MAGNESIUM SO4 10G/20ML INJ , MAGNESIUM SO4 25GM/50ML INJ , LEVOTHYROXINE NA 200MCG/VIL INJ , LEVOTHYROXINE NA 500MCG/VIL INJ , LEVOTHYROXINE NA 100MCG/VIL INJ , ADENOSINE 3MG/ML INJ , ADENOSINE 3MG/ML INJ,VIL,20ML , ADENOSINE 3MG/ML INJ,VIL,30ML , ADENOSINE 3MG/ML INJ,SYRINGE 2ML , ADENOSINE 3MG/ML INJ,SYRINGE 4ML , ESMOLOL HCL 10MG/ML INJ , CHLOROTHIAZIDE NA 500MG/VIL INJ , INDOMETHACIN NA 1MG/VIL INJ , METOPROLOL TARTRATE 5MG/ML INJ , DIPHENHYDRAMINE HCL 50MG/ML INJ , TERBUTALINE SO4 1MG/ML INJ , DEXMEDETOMIDINE 4MCG/ML/0.9% NACL INJ,BAG,100ML , DEXMEDETOMIDINE 4MCG/ML/0.9% NACL INJ,BAG,20ML , DEXMEDETOMIDINE 4MCG/ML/0.9% NACL INJ,BAG,50ML , PALONOSETRON HCL 50MCG/ML INJ,5ML , PALONOSETRON HCL 50MCG/ML INJ,SYRINGE,5ML , AMPICILLIN NA 500MG/VIL INJ , LEUCOVORIN CALCIUM 200MG/50ML VIL INJ , LEUCOVORIN CALCIUM 500MG/100ML VIL INJ , KABIVEN INF LIQ 870KCAL , PHENYLEPHRINE HCL 10MG/ML INJ , KABIVEN 1310KCAL /1540ML INFU, LIQ , KABIVEN 1745KCAL /2053ML INFU, LIQ , KABIVEN INF LIQ 2180KCAL , LINEZOLID 2MG/ML INJ,BAG,300ML , PERI KABIVEN INF LIQ 970KCAL , PERI KABIVEN INF LIQUID 1300KCAL/1920ML , PERI KABIVEN INF LIQ 1620KCAL , FULVESTRANT 50MG/ML INJ,SYRINGE,5ML , BORTEZOMIB 3.5MG/VIL INJ , REMIFENTANIL HCL 1MG/VIL INJ , REMIFENTANIL HCL 2MG/VIL INJ , REMIFENTANIL HCL 5MG/VIL INJ , MESNA 100MG/ML INJ , FAMOTIDINE 40MG/4ML SUSP,ORAL , FAMOTIDINE 10MG/ML INJ , MELPHALAN HCL 50MG/VIL INJ , TOPOTECAN HCL 4MG/VIL INJ , AMIKACIN SO4 250MG/ML INJ , SMOFLIPID 20GM/100ML INJ , SMOFLIPID 200GM/1000ML INJ , SMOFLIPID 100GM/500ML INJ , SMOFLIPID 50GM/250ML INJ , ERTAPENEM 1GM/VIL INJ , DEXTROSE 10% INJ,BAG,250ML , DEXTROSE 10% INJ,BAG,500ML , DEXTROSE 10% INJ,BAG,1000ML , MOXIFLOXACIN HCL 1.6MG/ML/NACL INJ,BAG,250ML , HYDROMORPHONE HCL 10MG/ML INJ , HYDROMORPHONE HCL 1MG/ML INJ , HYDROMORPHONE HCL 2MG/ML INJ , HYDROMORPHONE HCL 4MG/ML INJ , PENTAMIDINE ISETHIONATE 300MG/VIL SOLN,INHL , HEPARIN NA (PORK) 20000UNT/ML INJ , SODIUM CHLORIDE 0.9%/BENZYL ALCOHOL INJ,30ML , TIGECYCLINE 50MG/VIL INJ , POTASSIUM CHLORIDE 2MEQ/ML INJ , BENZTROPINE MESYLATE 1MG/ML INJ , FOSAPREPITANT DIMEGLUMINE 150MG/VIL INJ , PIPERACILLIN NA 2.25GM/TAZOBACTAM NA 0.25GM/VIL INJ , HYDROMORPHONE HCL 2MG/ML INJ,1ML , PIPERACILLIN NA 4.5GM/TAZOBACTAM NA 0.25GM/VIL INJ , PIPERACILLIN NA 3GM/TAZOBACTAM NA 0.375GM/VIL INJ , AMPICILLIN NA 250MG/VIL INJ , AMPICILLIN NA 1GM/VIL INJ , AMPICILLIN NA 2GM/VIL INJ , PHOSPHORUS 3MMOL/POTASSIUM 4.4MEQ/ML (PF) INJ , MIDAZOLAM HCL 1MG/ML (PF) INJ , MIDAZOLAM HCL 5MG/ML (PF) INJ , HYDROMORPHONE 1MG/ML INJ,SYRINGE,0.5ML , HYDROMORPHONE 0.5MG/0.5ML INJ,SYRINGE,0.5ML , HYDROMORPHONE HCL 1MG/ML INJ,1ML , METOCLOPRAMIDE HCL 5MG/ML INJ , ONDANSETRON HCL 2MG/ML (PF) INJ,SYRINGE,2ML , KETOROLAC TROMETHAMINE 30MG/ML INJ,SYRINGE,1ML , KETOROLAC TROMETHAMINE 30MG/ML INJ,SYRINGE,2ML , DEXAMETHASONE NA PHOSPHATE 4MG/ML INJ,SOLN,SYRINGE,1ML , KETOROLAC TROMETHAMINE 15MG/ML INJ,SYRINGE,1ML , HEPARIN NA 5000UNT/ML INJ , DEXAMETHASONE NA PHOSPHATE 10MG/ML INJ,SOLN,SYRINGE,1ML , HYDROMORPHONE HCL 0.2MG/ML INJ , GLYCOPYRROLATE 0.2MG/ML INJ,SYRINGE,1ML , GLYCOPYRROLATE 0.2MG/ML INJ,SYRINGE,2ML , NEOSTIGMINE METHYLSULFATE 1MG/ML INJ,SYR,3ML

Shared Drug Filings

79

Filings
See more under details

FDA Drug Shortage

4

Listed
Currently in Shortage 1
Drug Shortage Resolved 2
Drug to be Discontinued 1

FDA Production Site Inspection Outcomes since 2019

10 / 3

2019 / 2020 Inspections
No Action Indicated:
Fresenius Kabi USA, LLC - Melrose Park - IL - US - 2019-03-08
Fresenius Kabi USA LLC - Skokie - IL - US - 2020-03-05
Fresenius Medical Care Holdings, Inc. dba Fresenius Medical Care North America - Knoxville - TN - US - 2019-09-12
SGS Institut Fresenius Berlin GmbH & Co. KG - Berlin - - DE - 2019-06-17
SGS Institut Fresenius GmbH - Taunusstein - - DE - 2019-09-18

Voluntary Action Indicated:
Fresenius Kabi USA, LLC - Wilson - NC - US - 2019-02-05
Fresenius Medical Care, North America - Ogden - UT - US - 2020-08-13
Fresenius Medical Care Holdings, Inc. dba Fresenius Medical Care North America - Knoxville - TN - US - 2020-06-26
Fresenius Medical Care Holdings, Inc. - Waltham - MA - US - 2019-08-02
Fresenius Kabi USA, LLC - Grand Island - NY - US - 2019-08-12
Fresenius Kabi Austria GmbH - Graz - - AT - 2019-02-08
Fresenius Kabi Norge As - Halden - - NO - 2019-09-03
Fresenius Kabi iPSUM Srl - Villadose - - IT - 2019-12-06

Official Action Indicated:

Recent FDA Recalls (Abridged)

7

Recent Recalls
Fresenius - Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20 - Failed Impurities/Degradation Specifications.
11,981 units, 20190619

Fresenius - Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand] - Presence of Particulate Matter; glass particulates
14,016 vials, 20190724

Fresenius - Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. - Presence of Particulate Matter - found in reserve sample vials at the firm.
3,497,575 vials, 20200617

Fresenius - Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451 - CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
32,592 bags, 20200325

Fresenius - Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. - Presence of Particulate Matter - found in reserve sample vials at the firm.
5,314,400 vials, 20200617

Fresenius - Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-50 - Cross Contamination with other products: trace amounts of lidocaine
25,100 bottles, 20200902

Fresenius - Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10 - Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
63,067 vials, 20200722

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