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Last Updated: September 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202925

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NDA 202925 describes CLOPIDOGREL BISULFATE, which is a drug marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Celltrion, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Graviti Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Polygen Pharms, Prinston Inc, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, and Torrent Pharms Ltd, and is included in twenty-two NDAs. It is available from thirty-nine 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-one suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
Summary for 202925
Tradename:CLOPIDOGREL BISULFATE
Applicant:Accord Hlthcare
Ingredient:clopidogrel bisulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202925
Suppliers and Packaging for NDA: 202925
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 202925 ANDA Accord Healthcare Inc. 16729-218 16729-218-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-218-10)
CLOPIDOGREL BISULFATE clopidogrel bisulfate TABLET;ORAL 202925 ANDA Accord Healthcare Inc. 16729-218 16729-218-15 90 TABLET, FILM COATED in 1 BOTTLE (16729-218-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Mar 27, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Mar 27, 2013TE:ABRLD:No

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