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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 is included in two NDAs. It is available from five 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 NDA: 075128

Tradename:
AFEDITAB CR
Applicant:
Watson Labs
Ingredient:
nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075128

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

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 0591-3193-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3193-01)
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)

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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