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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Boehringer Ingelheim

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075659

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NDA 075659 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-one suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 075659
Applicant:Watson Labs
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075659
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 075659
Suppliers and Packaging for NDA: 075659
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AFEDITAB CR nifedipine TABLET, EXTENDED RELEASE;ORAL 075659 ANDA Actavis Pharma, Inc. 0591-3194 0591-3194-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3194-05)
AFEDITAB CR nifedipine TABLET, EXTENDED RELEASE;ORAL 075659 ANDA Actavis Pharma, Inc. 0591-3194 0591-3194-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3194-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Oct 26, 2001TE:AB1RLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim

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