Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076606
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Discontinued None No No
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Discontinued None No No
GABAPENTIN GABAPENTIN 400MG CAPSULE;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
10/07/2005 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
09/23/2011 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal

Label is not available on this site.

05/13/2010 SUPPL-8 Labeling

Label is not available on this site.

08/06/2007 SUPPL-5 Labeling

Label is not available on this site.

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