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Details for New Drug Application (NDA): 091023

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NDA 091023 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: 091023

Pharmacology for NDA: 091023

Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation

Suppliers and Packaging for NDA: 091023

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clopidogrel bisulfate
TABLET;ORAL 091023 ANDA Dr.Reddy's Laboratories Limited 55111-671 55111-671-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-671-01)
clopidogrel bisulfate
TABLET;ORAL 091023 ANDA Dr.Reddy's Laboratories Limited 55111-671 55111-671-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-671-05)

Summary for product number 001

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

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