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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 075108


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NDA 075108 describes NIFEDIPINE, which is a drug marketed by Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Leading, Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Martec Usa Llc, Mylan, Novast Labs, Osmotica Pharm Us, Par Pharm, Rising, Spil, Twi Pharms, Valeant Pharms North, Vitruvias, and Zydus Pharms, and is included in thirty NDAs. It is available from thirty-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. Thirty-seven suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 075108
Tradename:NIFEDIPINE
Applicant:Mylan
Ingredient:nifedipine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075108

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Dec 17, 1999TE:RLD:No

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