Details for New Drug Application (NDA): 204359

NDA 204359 describes CLOPIDOGREL BISULFATE, which is a drug marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Alkem Labs Ltd, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, MSN, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-five 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-four drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.

Summary for 204359

Tradename:	CLOPIDOGREL BISULFATE
Applicant:	Rising
Ingredient:	clopidogrel bisulfate
Patents:	0

Pharmacology for NDA: 204359

Mechanism of Action	Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Suppliers and Packaging for NDA: 204359

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	204359	ANDA	Graviti Pharmaceuticals Private Limited	69844-036	69844-036-01	30 TABLET in 1 BOTTLE (69844-036-01)
CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	204359	ANDA	Graviti Pharmaceuticals Private Limited	69844-036	69844-036-02	90 TABLET in 1 BOTTLE (69844-036-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 75MG BASE
Approval Date:	Feb 2, 2017	TE:	AB	RLD:	No

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