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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200491
Company: ANCHEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;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
06/27/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/2021 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

10/11/2019 SUPPL-12 Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-10 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/30/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

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