Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200651
Company: AUROBINDO PHARMA LTD
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
10/06/2011 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/15/2021 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/19/2020 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/19/2020 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/19/2020 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/19/2020 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/19/2020 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/18/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/31/2015 SUPPL-5 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

10/23/2014 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
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 214957 ASCENT PHARMS 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 077661 RUBICON
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 078926 ZYDUS PHARMS USA INC
NEURONTIN GABAPENTIN 600MG TABLET;ORAL Prescription Yes AB 020882 VIATRIS

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
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 214957 ASCENT PHARMS 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 077661 RUBICON
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 078926 ZYDUS PHARMS USA INC
NEURONTIN GABAPENTIN 800MG TABLET;ORAL Prescription Yes AB 020882 VIATRIS

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