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Last Updated: March 19, 2024

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. Nine 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022307
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 022307
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:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 10, 2009TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 10, 2009TE:ABRLD:Yes

Expired US Patents for NDA 022307

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

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