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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Julphar
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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075108

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NDA 075108 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-seven 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-three suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for 075108

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075108

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 075108

Suppliers and Packaging for NDA: 075108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 075108 ANDA State of Florida DOH Central Pharmacy 53808-0744 53808-0744-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0744-1)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Julphar
Boehringer Ingelheim
Federal Trade Commission
Johnson and Johnson
Medtronic
QuintilesIMS
Moodys
Chubb
Healthtrust
Argus Health

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