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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202266
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Discontinued None No No
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG 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
11/20/2012 ORIG-2 Approval

Label is not available on this site.

08/14/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/28/2022 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/21/2021 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/24/2020 SUPPL-7 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

03/24/2020 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

03/24/2020 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

12/11/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/11/2015 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

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