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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077410

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NDA 077410 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-seven 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-three suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for 077410

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077410

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 077410

Suppliers and Packaging for NDA: 077410

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 077410 ANDA Rebel Distributors Corp 21695-807 21695-807-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-807-90)
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 077410 ANDA Rebel Distributors Corp 21695-807 21695-807-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-807-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Oct 3, 2007TE:AB2RLD:No


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Serving leading biopharmaceutical companies globally:

Medtronic
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Julphar
Novartis
Citi
Deloitte
Baxter
McKesson

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