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Details for New Drug Application (NDA): 022307

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NDA 022307 describes EFFIENT, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. 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. Three suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

Summary for NDA: 022307

Formulation / Manufacturing:see details

Pharmacology for NDA: 022307

Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation

Suppliers and Packaging for NDA: 022307

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
prasugrel hydrochloride
TABLET;ORAL 022307 NDA Eli Lilly and Company 0002-5121 0002-5121-30 30 TABLET, FILM COATED in 1 BOTTLE (0002-5121-30)
prasugrel hydrochloride
TABLET;ORAL 022307 NDA Eli Lilly and Company 0002-5121 0002-5121-52 24 BLISTER PACK in 1 CARTON (0002-5121-52) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0002-5121-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 10, 2009TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 12, 2019
Regulatory Exclusivity Use:
Patent:5,288,726*PEDPatent Expiration:Oct 14, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:8,404,703*PEDPatent Expiration:Jul 2, 2023Product Flag?Substance Flag?Delist Request?Y

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