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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078004


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NDA 078004 describes CLOPIDOGREL BISULFATE, which is a drug marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Alkem Labs Ltd, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-four NDAs. It is available from forty-one suppliers. Additional details are available on the CLOPIDOGREL BISULFATE profile page.

The generic ingredient in CLOPIDOGREL BISULFATE is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 078004
Tradename:CLOPIDOGREL BISULFATE
Applicant:Acme Labs
Ingredient:clopidogrel bisulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078004
Suppliers and Packaging for NDA: 078004
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 078004 ANDA ACI Healthcare USA, Inc 71093-142 71093-142-04 90 TABLET, FILM COATED in 1 BOTTLE (71093-142-04)
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 078004 ANDA ACI Healthcare USA, Inc 71093-142 71093-142-05 500 TABLET, FILM COATED in 1 BOTTLE (71093-142-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:May 17, 2012TE:ABRLD:No

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