Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077661
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription AB No No
GABAPENTIN GABAPENTIN 800MG 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
09/13/2006 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-13 Labeling-Package Insert

Label is not available on this site.

04/17/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/09/2013 SUPPL-9 REMS

Label is not available on this site.

04/17/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/26/2011 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/31/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/03/2010 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

GABAPENTIN

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 203244 ACI HEALTHCARE LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 075694 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 206402 ALKEM LABS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 077661 APOTEX INC
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 200651 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 207057 CSPC OUYI
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 077662 GLENMARK PHARMS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 202764 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 076017 IVAX SUB TEVA PHARMS
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 209306 LUPIN LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 090335 MYLAN PHARMS INC
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 205101 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 077525 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 205807 TEVA PHARMS USA
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 078926 ZYDUS PHARMS USA INC
NEURONTIN GABAPENTIN 600MG TABLET;ORAL Prescription Yes AB 020882 PFIZER PHARMS

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 203244 ACI HEALTHCARE LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 075694 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 206402 ALKEM LABS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 077661 APOTEX INC
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 200651 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 207057 CSPC OUYI
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 077662 GLENMARK PHARMS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 202764 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 076017 IVAX SUB TEVA PHARMS
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 209306 LUPIN LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 090335 MYLAN PHARMS INC
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 205101 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 077525 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 205807 TEVA PHARMS USA
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 078926 ZYDUS PHARMS USA INC
NEURONTIN GABAPENTIN 800MG TABLET;ORAL Prescription Yes AB 020882 PFIZER PHARMS

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