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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 205913

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NDA 205913 describes PRASUGREL, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Hec Pharm, Mylan, Panacea Biotec Ltd, and Uspharma Windlas, and is included in seven NDAs. It is available from twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
Summary for 205913
Applicant:Amneal Pharms
Ingredient:prasugrel hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 205913
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 205913
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 A-S Medication Solutions 50090-4118 50090-4118-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-4118-0)
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jun 19, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jun 19, 2018TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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