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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 213315


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NDA 213315 describes PRASUGREL HYDROCHLORIDE, which is a drug marketed by Unichem and is included in one NDA. It is available from one supplier. Additional details are available on the PRASUGREL HYDROCHLORIDE profile page.

The generic ingredient in PRASUGREL HYDROCHLORIDE 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 213315
Tradename:PRASUGREL HYDROCHLORIDE
Applicant:Unichem
Ingredient:prasugrel hydrochloride
Patents:0
Pharmacology for NDA: 213315
Mechanism of ActionP2Y12 Receptor Antagonists
Physiological EffectDecreased Platelet Aggregation
Medical Subject Heading (MeSH) Categories for 213315
Suppliers and Packaging for NDA: 213315
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRASUGREL HYDROCHLORIDE prasugrel hydrochloride TABLET;ORAL 213315 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-301 29300-301-13 30 TABLET, FILM COATED in 1 BOTTLE (29300-301-13)
PRASUGREL HYDROCHLORIDE prasugrel hydrochloride TABLET;ORAL 213315 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-302 29300-302-13 30 TABLET, FILM COATED in 1 BOTTLE (29300-302-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Aug 28, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Aug 28, 2023TE:ABRLD:No

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