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Generated: November 21, 2018

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Details for New Drug Application (NDA): 205790

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NDA 205790 describes PRASUGREL, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Mylan Pharms Inc, Panacea Biotec Ltd, and Uspharma Windlas, and is included in six NDAs. It is available from six 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. Eight suppliers are listed for this compound. Additional details are available on the prasugrel hydrochloride profile page.
Summary for 205790
Tradename:PRASUGREL
Applicant:Uspharma Windlas
Ingredient:prasugrel hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205790
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 205790
Suppliers and Packaging for NDA: 205790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRASUGREL prasugrel hydrochloride TABLET;ORAL 205790 ANDA Ascend Laboratories, LLC 67877-604 67877-604-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-604-30)
PRASUGREL prasugrel hydrochloride TABLET;ORAL 205790 ANDA Ascend Laboratories, LLC 67877-605 67877-605-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-605-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Oct 16, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Oct 16, 2017TE:ABRLD:No

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