Details for New Drug Application (NDA): 022307

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NDA 022307 describes EFFIENT, which is a drug marketed by Cosette and is included in one NDA. It is available from one supplier. Additional details are available on the EFFIENT profile page.

The generic ingredient in EFFIENT is prasugrel hydrochloride. There are nineteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

Summary for 022307

Tradename:	EFFIENT
Applicant:	Cosette
Ingredient:	prasugrel hydrochloride
Patents:	0

Pharmacology for NDA: 022307

Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Medical Subject Heading (MeSH) Categories for 022307

Platelet Aggregation Inhibitors

Suppliers and Packaging for NDA: 022307

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Cosette Pharmaceuticals, Inc.	0713-0881	0713-0881-30	30 TABLET, COATED in 1 BOTTLE (0713-0881-30)
EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Cosette Pharmaceuticals, Inc.	0713-0882	0713-0882-30	30 TABLET, COATED in 1 BOTTLE (0713-0882-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 10, 2009	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jul 10, 2009	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022307

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	⤷ Subscribe	⤷ Subscribe
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-001	Jul 10, 2009	⤷ Subscribe	⤷ Subscribe
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307-002	Jul 10, 2009	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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