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FDA Drug NDCs and Drug Labels
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FDA Drug NDCs / Labels

86

Total Labels
NDA Filings palbocicl , Daltepari , tofacitin , Sunitinib , piroxicam , azithromy , sildenafi , prazosin , hydroxyzi , quinapril , gabapenti , liothyron , levothyro , nafarelin , spironola , misoprost , Celecoxib , conjugate , Heparin S , Bosutinib , lorlatini , talazopar , glasdegib , doxycycli , dacomitin , amlodipin , atorvasta , PREGABALI , SIROLIMUS , TIGECYCLI , TAZOBACTA , metaxalon , diclofena , Metronida , fesoterod , varenicli , Doxorubic , Fosphenyt , nitroglyc , VENLAFAXI , desvenlaf , PANTOPRAZ , penicilli , ramipril , estrogens , tafamidis , ethionami , diphenoxy , verapamil , disopyram , Meropenem , gemfibroz , trimethob , benzonata , dofetilid , CRIZOTINI , methsuxim , neomycin , nifedipin , Phenytoin , crisaboro , eplerenon , axitinib , Ethosuxim , Phenelzin , echothiop , temsiroli , silver su , quinupris , oxaprozin
Authorized Generic Drugs romidepsi
ANDAs (Approved New Drug Applications) Phenytoin , penicilli , esterifie , Propofol , Ethosuxim , Extended , methimazo , AMPICILLI
Unapproved Drugs azithromy
BLA Taligluce , bevacizum , epoetin a , Coral Sna , trastuzum , inotuzuma , filgrasti , gemtuzuma , rituximab , inflixima
Vertically Integrated (estimated) doxorub, heparin, neomyci, hydroxy,
Private labels
NovaPlus Pfizer Laboratories Div Pfizer Inc - Doxorubicin Hydrochloride - INTRAVENOUS - 0069-4031-01 - 2 mg/mL
Premier Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer - TIGECYCLINE - INTRAVENOUS - 0008-4994-20 - 50 mg/5mL
Premier Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer - PANTOPRAZOLE SODIUM - INTRAVENOUS - 0008-4001-10, 0008-4001-25 - 40 mg/10mL
Premier Pfizer Laboratories Div Pfizer Inc - Doxorubicin Hydrochloride - INTRAVENOUS - 0069-4026-25 - 2 mg/mL

FDA Drug NDCs and Drug Labels Developed through combinations of orange book, dailymed and openFDA

Drug Manufacturer Route Strength NDCs Type Application Holder Approval Date PI / Labels
taliglucerase alfa Pfizer Laborato intravenous 200 U/5mL 0069-0106-01 BLA 2012-05-01
palbociclib Pfizer Laborato oral 75 mg/1 0069-0187-21 NDA PFIZER 2015-02-03
palbociclib Pfizer Laborato oral 100 mg/1 0069-0188-21 NDA PFIZER 2015-02-03
dalteparin sodium Pfizer Laborato subcutaneous 5000 [iU]/.2mL 0069-0196-02 NDA PFIZER 2002-04-04