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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202764
Company: INVAGEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Discontinued None No No
GABAPENTIN GABAPENTIN 800MG 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
10/16/2012 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
06/02/2021 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/02/2021 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/02/2021 SUPPL-21 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/02/2021 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/02/2021 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

06/02/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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