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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 205987

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NDA 205987 describes PRASUGREL, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Anda Repository, Aurobindo Pharma, Chartwell Rx, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the PRASUGREL profile page.

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

Summary for 205987

Tradename:	PRASUGREL
Applicant:	Accord Hlthcare
Ingredient:	prasugrel hydrochloride
Patents:	0

Pharmacology for NDA: 205987

Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Medical Subject Heading (MeSH) Categories for 205987

Platelet Aggregation Inhibitors

Suppliers and Packaging for NDA: 205987

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205987	ANDA	Accord Healthcare Inc.	16729-272	16729-272-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-272-10)
PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205987	ANDA	Accord Healthcare Inc.	16729-273	16729-273-10	30 TABLET, FILM COATED in 1 BOTTLE (16729-273-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Feb 2, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Feb 2, 2018	TE:	AB	RLD:	No

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