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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 205987


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NDA 205987 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 205987
Tradename:PRASUGREL
Applicant:Accord Hlthcare
Ingredient:prasugrel hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205987
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 205987
Suppliers and Packaging for NDA: 205987
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRASUGREL prasugrel hydrochloride TABLET;ORAL 205987 ANDA Accord Healthcare Inc. 16729-272 16729-272-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-272-10)
PRASUGREL prasugrel hydrochloride TABLET;ORAL 205987 ANDA Accord Healthcare Inc. 16729-273 16729-273-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-273-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Feb 2, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 2, 2018TE:ABRLD:No

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