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Serving 500+ biopharmaceutical companies globally:

Moodys
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AstraZeneca
Medtronic
Fuji
McKinsey
Farmers Insurance
US Army
Citi
Dow

Generated: August 23, 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 Mylan Labs Ltd, Mylan, Chase Labs Nj, Osmotica Pharm Us, Martec Usa Llc, Twi Pharms Inc, Heritage Pharma, Validus Pharms, Teva, Actavis Elizabeth, Valeant Pharms North, Intergel Pharm, Novast Labs Ltd, and Par Pharm, 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-four suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for NDA: 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

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 21695-807-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (21695-807-30)
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)

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 500+ biopharmaceutical companies globally:

US Department of Justice
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Cantor Fitzgerald
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