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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
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Accenture
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Express Scripts
Cipla
Moodys
McKesson
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Fish and Richardson

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075289

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NDA 075289 describes NIFEDIPINE, which is a drug marketed by Mylan Labs Ltd, Mylan, Chase Labs Nj, Osmotica Pharm, Martec Usa Llc, Twi Pharms Inc, Osmotica Pharm Us, 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-six 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 NDA: 075289

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

Pharmacology for NDA: 075289

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 075289

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE
nifedipine
TABLET, EXTENDED RELEASE;ORAL 075289 ANDA Teva Pharmaceuticals USA Inc 0093-0819 0093-0819-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-0819-01)
NIFEDIPINE
nifedipine
TABLET, EXTENDED RELEASE;ORAL 075289 ANDA Teva Pharmaceuticals USA Inc 0093-0819 0093-0819-55 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-0819-55)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Sep 27, 2000TE:AB2RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Feb 6, 2001TE:AB2RLD:No


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Healthtrust
Baxter
Chubb
Daiichi Sankyo
Accenture
Express Scripts
Chinese Patent Office
Cipla

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