Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076017
Company: IVAX SUB TEVA PHARMS
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
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
04/28/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76017ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/20/2015 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

07/20/2015 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

07/19/2012 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

04/16/2012 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

09/29/2011 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

08/25/2011 SUPPL-30 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

11/18/2009 SUPPL-25 Labeling

Label is not available on this site.

07/14/2008 SUPPL-24 Labeling

Label is not available on this site.

04/28/2008 SUPPL-22 Labeling

Label is not available on this site.

01/17/2008 SUPPL-20 Labeling

Label is not available on this site.

12/20/2005 SUPPL-12 Labeling

Label is not available on this site.

04/29/2005 SUPPL-9

Label is not available on this site.

04/29/2005 SUPPL-6 Labeling

Label is not available on this site.

04/29/2005 SUPPL-5

Label is not available on this site.

04/29/2005 SUPPL-4

Label is not available on this site.

09/20/2004 SUPPL-2 Labeling

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

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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