Last Updated: November 8, 2026

Details for New Drug Application (NDA): 205897

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NDA 205897 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 205897

Tradename:	PRASUGREL
Applicant:	Panacea
Ingredient:	prasugrel hydrochloride
Patents:	0

Pharmacology for NDA: 205897

Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Medical Subject Heading (MeSH) Categories for 205897

Platelet Aggregation Inhibitors

Suppliers and Packaging for NDA: 205897

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205897	ANDA	Panacea Biotec Limited	43817-239	43817-239-01	30 TABLET, FILM COATED in 1 BOTTLE (43817-239-01)
PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205897	ANDA	Apotex Corp.	60505-4642	60505-4642-3	30 TABLET, FILM COATED in 1 BOTTLE (60505-4642-3)

Profile for product number 001

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

Profile for product number 002

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

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