You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Details for New Drug Application (NDA): 205897


✉ Email this page to a colleague

« Back to Dashboard


NDA 205897 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 205897
Tradename:PRASUGREL
Applicant:Panacea
Ingredient:prasugrel hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205897
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 205897
Suppliers and Packaging for NDA: 205897
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRASUGREL prasugrel hydrochloride TABLET;ORAL 205897 ANDA Panacea Biotec Limited 43817-239 43817-239-01 30 TABLET, FILM COATED in 1 BOTTLE (43817-239-01)
PRASUGREL prasugrel hydrochloride TABLET;ORAL 205897 ANDA Panacea Biotec Limited 43817-240 43817-240-01 30 TABLET, FILM COATED in 1 BOTTLE (43817-240-01)

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.