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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Fuji
Julphar
McKesson
Boehringer Ingelheim
Federal Trade Commission
Cipla
Baxter
UBS

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077899

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NDA 077899 describes NIFEDIPINE, which is a drug marketed by Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Intergel Pharm, Teva, Validus Pharms, Martec Usa Llc, Mylan, Mylan Labs Ltd, Novast Labs Ltd, Osmotica Pharm Us, Par Pharm, Twi Pharms Inc, Valeant Pharms North, and Zydus Pharms Usa Inc, and is included in twenty-three NDAs. It is available from forty-four suppliers. Additional details are available on the NIFEDIPINE profile page.

The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 077899
Tradename:NIFEDIPINE
Applicant:Par Pharm
Ingredient:nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077899
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 077899
Suppliers and Packaging for NDA: 077899
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 077899 ANDA Major Pharmaceuticals 0904-6544 N 0904-6544-61
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 077899 ANDA Major Pharmaceuticals 0904-6545 N 0904-6545-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Dec 13, 2006TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Dec 13, 2006TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:May 25, 2012TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Medtronic
Harvard Business School
Boehringer Ingelheim
Fuji
US Army
Fish and Richardson
Daiichi Sankyo
Teva

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