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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205790
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None No No
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Discontinued None 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
10/16/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205790Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2022 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/04/2019 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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

Label is not available on this site.

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