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Details for New Drug Application (NDA): 078133

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NDA 078133 describes CLOPIDOGREL BISULFATE, which is a drug marketed by Roxane, Actavis Totowa, Gate Pharms, Dr Reddys Labs Ltd, Accord Hlthcare, Teva Pharms, Macleods Pharms Ltd, Sun Pharm Inds, Aurobindo Pharma Ltd, Torrent Pharms Ltd, Amneal Pharms, Mylan Pharms Inc, Sciegen Pharms Inc, Wockhardt Ltd, Dr Reddys Labs Inc, Apotex Inc, Zydus Pharms Usa Inc, Sun Pharma Global, and Teva, and is included in nineteen NDAs. It is available from forty-two 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-eight suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.

Summary for NDA: 078133

Tradename:
CLOPIDOGREL BISULFATE
Applicant:
Sun Pharm Inds
Ingredient:
clopidogrel bisulfate
Patents:0
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Jun 10, 2013TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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