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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cipla
Cantor Fitzgerald
Novartis
UBS
Chubb
Boehringer Ingelheim
Healthtrust
Federal Trade Commission
US Department of Justice

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077127

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NDA 077127 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, and Valeant Pharms North, and is included in twenty-two NDAs. It is available from forty-five 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-one suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 077127
Tradename:NIFEDIPINE
Applicant:Osmotica Pharm Us
Ingredient:nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077127
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 077127
Suppliers and Packaging for NDA: 077127
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 077127 ANDA Rebel Distributors Corp 21695-908 21695-908-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-908-30)
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 077127 ANDA Rebel Distributors Corp 42254-095 42254-095-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42254-095-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Nov 21, 2005TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Nov 21, 2005TE:AB2RLD:No

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Serving leading biopharmaceutical companies globally:

Cipla
Medtronic
Fish and Richardson
UBS
Chubb
Colorcon
Daiichi Sankyo
McKinsey
Healthtrust

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