Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075827
Company: TEVA
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
12/15/2004 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
05/21/2012 SUPPL-9 Labeling

Label is not available on this site.

04/16/2012 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/10/2006 SUPPL-3 Labeling

Label is not available on this site.

05/20/2005 SUPPL-1 Labeling

Label is not available on this site.

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