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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205913
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription BX No No
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription BX No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/19/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/04/2022 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/04/2019 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

PRASUGREL

There are no Therapeutic Equivalents.

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