Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078782
Company: HIKMA 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
07/21/2011 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
02/29/2016 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/28/2012 SUPPL-2 Labeling-Package Insert, REMS-Modified

Label is not available on this site.

04/17/2012 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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