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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072556

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NDA 072556 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 072556

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

Pharmacology for NDA: 072556

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 072556

Suppliers and Packaging for NDA: 072556

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine CAPSULE;ORAL 072556 ANDA Actavis Pharma, Inc. 0228-2530 0228-2530-10 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0228-2530-10)
NIFEDIPINE nifedipine CAPSULE;ORAL 072556 ANDA AvPAK 50268-601 50268-601-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-601-15) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-601-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Sep 20, 1990TE:ABRLD:No


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