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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 090844


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NDA 090844 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, MSN, 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-five 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 090844
Tradename:CLOPIDOGREL BISULFATE
Applicant:Torrent Pharms Ltd
Ingredient:clopidogrel bisulfate
Patents:0
Pharmacology for NDA: 090844
Suppliers and Packaging for NDA: 090844
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 090844 ANDA Major Pharmaceuticals 0904-6294 0904-6294-61 100 BLISTER PACK in 1 CARTON (0904-6294-61) / 1 TABLET in 1 BLISTER PACK
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 090844 ANDA Torrent Pharmaceuticals Limited 13668-141 13668-141-01 100 TABLET in 1 BOTTLE (13668-141-01)

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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