Last Updated: September 28, 2026

Details for New Drug Application (NDA): 206021

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NDA 206021 describes PRASUGREL, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Hec Pharm, Lupin, Mylan, Panacea, Senores Pharms, 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 206021

Tradename:	PRASUGREL
Applicant:	Hec Pharm
Ingredient:	prasugrel hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 206021

Platelet Aggregation Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jan 16, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jan 16, 2019	TE:	AB	RLD:	No

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