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Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201686

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NDA 201686 describes CLOPIDOGREL BISULFATE, which is a drug marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Gate Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Sciegen Pharms Inc, Sun Pharm Industries, Sun Pharma Global, Teva, Teva Pharms, Torrent Pharms Ltd, Wockhardt Ltd, and Zydus Pharms Usa Inc, and is included in twenty NDAs. It is available from fifty suppliers. Additional details are available on the CLOPIDOGREL BISULFATE profile page.

The generic ingredient in CLOPIDOGREL BISULFATE is clopidogrel bisulfate. There are fifty-three drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 201686
Tradename:CLOPIDOGREL BISULFATE
Applicant:Zydus Pharms Usa Inc
Ingredient:clopidogrel bisulfate
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 201686
Suppliers and Packaging for NDA: 201686
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 201686 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1417 70710-1417-3 30 TABLET, FILM COATED in 1 BOTTLE (70710-1417-3)
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 201686 ANDA Zydus Pharmaceuticals (USA) Inc. 70710-1417 70710-1417-9 90 TABLET, FILM COATED in 1 BOTTLE (70710-1417-9)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Oct 10, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
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QuintilesIMS
Cantor Fitzgerald
Johnson and Johnson
Moodys
McKinsey
Cerilliant
Covington

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