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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203126

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NDA 203126 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, Valeant Pharms North, and Zydus Pharms Usa Inc, and is included in twenty-three NDAs. It is available from forty 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. Forty-five suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 203126
Tradename:NIFEDIPINE
Applicant:Twi Pharms Inc
Ingredient:nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203126
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 203126
Suppliers and Packaging for NDA: 203126
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 203126 ANDA TWi Pharmaceuticals, Inc. 24979-009 N 24979-009-01
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 203126 ANDA TWi Pharmaceuticals, Inc. 24979-009 N 24979-009-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Apr 3, 2014TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 3, 2014TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Apr 3, 2014TE:AB2RLD:No

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