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Last Updated: May 11, 2021

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Details for New Drug Application (NDA): 210012

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NDA 210012 describes NIFEDIPINE, which is a drug marketed by Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Leading Pharma Llc, Teva, Elite, Martec Usa Llc, Mylan, Mylan Labs Ltd, Novast Labs, Osmotica Pharm Us, Par Pharm, Spil, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in twenty-six NDAs. It is available from thirty-two 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-four suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 210012
Tradename:NIFEDIPINE
Applicant:Zydus Pharms
Ingredient:nifedipine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210012
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 210012
Suppliers and Packaging for NDA: 210012
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 210012 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-685 68382-685-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-685-01)
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 210012 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-685 68382-685-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-685-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Dec 19, 2017TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Dec 19, 2017TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Dec 19, 2017TE:AB2RLD:No

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