Details for New Drug Application (NDA): 205913

NDA 205913 describes PRASUGREL, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hec Pharm, Lupin Ltd, Mylan, Panacea, and Unichem, and is included in ten NDAs. It is available from seven 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. Nine suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.

Summary for 205913

Tradename:	PRASUGREL
Applicant:	Amneal Pharms
Ingredient:	prasugrel hydrochloride
Patents:	0

Pharmacology for NDA: 205913

Mechanism of Action	P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Medical Subject Heading (MeSH) Categories for 205913

Platelet Aggregation Inhibitors

Suppliers and Packaging for NDA: 205913

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205913	ANDA	Amneal Pharmaceuticals LLC	65162-001	65162-001-03	30 TABLET, FILM COATED in 1 BOTTLE (65162-001-03)
PRASUGREL	prasugrel hydrochloride	TABLET;ORAL	205913	ANDA	Amneal Pharmaceuticals LLC	65162-002	65162-002-03	30 TABLET, FILM COATED in 1 BOTTLE (65162-002-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jun 19, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jun 19, 2018	TE:	AB	RLD:	No

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