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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077665

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NDA 077665 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 forty-eight 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. Forty-nine suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 077665
Tradename:CLOPIDOGREL BISULFATE
Applicant:Mylan Pharms Inc
Ingredient:clopidogrel bisulfate
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Pharmacology for NDA: 077665
Suppliers and Packaging for NDA: 077665
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 077665 ANDA Mylan Pharmaceuticals Inc. 0378-3627 N 0378-3627-77
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 077665 ANDA Mylan Pharmaceuticals Inc. 0378-3627 N 0378-3627-05

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:May 17, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
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Deloitte
Healthtrust
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Moodys

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