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Serving leading biopharmaceutical companies globally:

Cerilliant
Baxter
US Department of Justice
Deloitte
Merck
Cipla
Moodys
Medtronic
Argus Health
Mallinckrodt

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201071

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NDA 201071 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 201071
Tradename:NIFEDIPINE
Applicant:Mylan
Ingredient:nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201071
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 201071
Suppliers and Packaging for NDA: 201071
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 201071 ANDA Mylan Pharmaceuticals Inc. 0378-0353 0378-0353-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0353-01)
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 201071 ANDA Mylan Pharmaceuticals Inc. 0378-0353 0378-0353-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0353-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Dec 3, 2010TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Dec 3, 2010TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Dec 3, 2010TE:AB1RLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
UBS
Cantor Fitzgerald
Chinese Patent Office
Citi
Federal Trade Commission
AstraZeneca
Fish and Richardson

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