Last Updated: November 8, 2026

Details for New Drug Application (NDA): 205790

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NDA 205790 describes PRASUGREL, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Hec Pharm, Lupin, Mylan, Panacea, Pharmazone, 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 is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

Summary for 205790

Tradename:	PRASUGREL
Applicant:	Chartwell Rx
Ingredient:	prasugrel hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 205790

Platelet Aggregation Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Oct 16, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Oct 16, 2017	TE:		RLD:	No

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