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Generated: June 17, 2018

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 suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 075128
Applicant:Watson Labs Teva
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 N 0591-3193-01
AFEDITAB CR nifedipine TABLET, EXTENDED RELEASE;ORAL 075128 ANDA Actavis Pharma, Inc. 0591-3193 N 0591-3193-05

Profile for product number 001

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

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