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Generated: May 27, 2019

DrugPatentWatch Database Preview

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, Aurobindo Pharma Ltd, Hec Pharm, Mylan Pharms Inc, Panacea Biotec Ltd, and Uspharma Windlas, and is included in seven NDAs. It is available from ten 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 Pharms Inc
Ingredient:prasugrel hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205927
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 205927
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:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 12, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 12, 2017TE:ABRLD:No

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