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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078926
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription AB1 No No
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription AB1 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
02/11/2011 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
10/03/2024 SUPPL-19 Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/09/2021 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

10/28/2020 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/28/2020 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/28/2020 SUPPL-12 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/28/2020 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/28/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/08/2014 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2014 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/11/2012 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/30/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

GABAPENTIN

TABLET;ORAL; 600MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 075694 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 206402 ALKEM LABS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 214957 ASCENT PHARMS INC
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 200651 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 207057 CSPC OUYI
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 077662 GLENMARK PHARMS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 217116 GRANULES
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 209855 IPCA LABS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 217965 LAURUS
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 217995 RISING
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 077661 RUBICON
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 205101 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 203244 STRIDES PHARMA
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 211313 STRIDES PHARMA
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 077525 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB1 078926 ZYDUS PHARMS USA INC
NEURONTIN GABAPENTIN 600MG TABLET;ORAL Prescription Yes AB1 020882 VIATRIS

TABLET;ORAL; 800MG
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 075694 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 206402 ALKEM LABS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 214957 ASCENT PHARMS INC
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 200651 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 207057 CSPC OUYI
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 077662 GLENMARK PHARMS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 217116 GRANULES
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 209855 IPCA LABS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 217965 LAURUS
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 217995 RISING
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 077661 RUBICON
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 205101 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 203244 STRIDES PHARMA
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 211313 STRIDES PHARMA
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 077525 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB1 078926 ZYDUS PHARMS USA INC
NEURONTIN GABAPENTIN 800MG TABLET;ORAL Prescription Yes AB1 020882 VIATRIS
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