BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Chinese Patent Office
Accenture
Fuji
Cipla
Medtronic
Queensland Health
Mallinckrodt
Johnson and Johnson

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074045

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NDA 074045 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 074045
Tradename:NIFEDIPINE
Applicant:Validus Pharms
Ingredient:nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074045
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 074045
Suppliers and Packaging for NDA: 074045
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine CAPSULE;ORAL 074045 ANDA Leading Pharma, LLC 69315-212 69315-212-01 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-212-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Apr 30, 1992TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Novartis
Cerilliant
QuintilesIMS
Colorcon
Cantor Fitzgerald
Baxter
Deloitte
Chubb
UBS

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