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Details for New Drug Application (NDA): 201686

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NDA 201686 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, Cspc Ouyi Pharm Co, 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 twenty NDAs. It is available from forty-five 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-one suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.

Summary for NDA: 201686

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 70710-1417-0 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1417-0)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Oct 10, 2012TE: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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