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Serving leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Queensland Health
US Army

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075128

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NDA 075128 describes AFEDITAB CR, which is a drug marketed by Watson Labs and Watson Labs Teva and is included in two NDAs. It is available from four suppliers. Additional details are available on the AFEDITAB CR profile page.

The generic ingredient in AFEDITAB CR 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 075128

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075128

Mechanism of ActionCalcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 075128

Suppliers and Packaging for NDA: 075128

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AFEDITAB CR nifedipine TABLET, EXTENDED RELEASE;ORAL 075128 ANDA Actavis Pharma, Inc. 0591-3193 0591-3193-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3193-05)
AFEDITAB CR nifedipine TABLET, EXTENDED RELEASE;ORAL 075128 ANDA Actavis Pharma, Inc. 0591-3193 0591-3193-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3193-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Mar 10, 2000TE:AB1RLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Express Scripts

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