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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072781

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NDA 072781 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 072781
Tradename:NIFEDIPINE
Applicant:Intergel Pharm
Ingredient:nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 072781
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 072781
Suppliers and Packaging for NDA: 072781
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine CAPSULE;ORAL 072781 ANDA GAVIS Pharmaceuticals, LLC 43386-440 43386-440-24 100 CAPSULE in 1 BOTTLE (43386-440-24)
NIFEDIPINE nifedipine CAPSULE;ORAL 072781 ANDA PD-Rx Pharmaceuticals, Inc. 55289-907 55289-907-79 1 CAPSULE in 1 BOTTLE, PLASTIC (55289-907-79)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jul 30, 1993TE:ABRLD:No

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