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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 205927

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NDA 205927 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 205927

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

Pharmacology for NDA: 205927

Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Medical Subject Heading (MeSH) Categories for 205927

Platelet Aggregation Inhibitors

Suppliers and Packaging for NDA: 205927

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205927	ANDA	Mylan Pharmaceuticals Inc.	0378-5185	0378-5185-93	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5185-93)
PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205927	ANDA	Mylan Pharmaceuticals Inc.	0378-5186	0378-5186-93	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5186-93)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 12, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jul 12, 2017	TE:	AB	RLD:	No

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