Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077894
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 100MG TABLET;ORAL Prescription AB No No
GABAPENTIN GABAPENTIN 300MG TABLET;ORAL Prescription AB No No
GABAPENTIN GABAPENTIN 400MG TABLET;ORAL Prescription AB 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
10/10/2006 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
09/17/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/17/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

04/17/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/11/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

GABAPENTIN

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 100MG TABLET;ORAL Prescription No AB 077894 APOTEX INC
GABAPENTIN GABAPENTIN 100MG TABLET;ORAL Prescription No AB 076017 IVAX SUB TEVA PHARMS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 300MG TABLET;ORAL Prescription No AB 077894 APOTEX INC
GABAPENTIN GABAPENTIN 300MG TABLET;ORAL Prescription No AB 076017 IVAX SUB TEVA PHARMS

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 400MG TABLET;ORAL Prescription No AB 077894 APOTEX INC
GABAPENTIN GABAPENTIN 400MG TABLET;ORAL Prescription No AB 076017 IVAX SUB TEVA PHARMS

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