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Details for New Drug Application (NDA): 090602

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NDA 090602 describes NIFEDIPINE, which is a drug marketed by Matrix 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-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 NDA: 090602

Tradename:
NIFEDIPINE
Applicant:
Matrix Labs Ltd
Ingredient:
nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Sep 13, 2010TE:AB2RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Sep 13, 2010TE:AB2RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Sep 13, 2010TE:AB2RLD:No


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