U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078428
Company: AMNEAL PHARMS NY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription AB No No
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription AB No No
GABAPENTIN GABAPENTIN 400MG CAPSULE;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
07/25/2007 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
08/02/2023 SUPPL-53 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/02/2023 SUPPL-47 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/21/2020 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/21/2020 SUPPL-36 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/21/2020 SUPPL-33 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/08/2016 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-29 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

11/08/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

04/23/2014 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

04/19/2012 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/30/2011 SUPPL-15 Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Package Insert

Label is not available on this site.

12/16/2011 SUPPL-14 Labeling

Label is not available on this site.

04/17/2012 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

05/17/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/17/2010 SUPPL-4 Labeling

Label is not available on this site.

GABAPENTIN

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 075350 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090858 ALKEM
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 078428 AMNEAL PHARMS NY
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 214956 ASCENT PHARMS INC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 075477 CSPC OUYI
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 075360 GRANULES
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 208928 IPCA LABS LTD
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 217546 LAURUS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 207099 RISING
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 206943 STRIDES PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 077261 TARO
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 213603 ZHEJIANG YONGTAI
NEURONTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription Yes AB 020235 VIATRIS

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 075350 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090858 ALKEM
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 078428 AMNEAL PHARMS NY
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 214956 ASCENT PHARMS INC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 075477 CSPC OUYI
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 075360 GRANULES
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 208928 IPCA LABS LTD
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 217546 LAURUS
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 207099 RISING
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 206943 STRIDES PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 077261 TARO
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 213603 ZHEJIANG YONGTAI
NEURONTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription Yes AB 020235 VIATRIS

CAPSULE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 075350 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090858 ALKEM
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 078428 AMNEAL PHARMS NY
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 214956 ASCENT PHARMS INC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 075477 CSPC OUYI
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 075360 GRANULES
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 208928 IPCA LABS LTD
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 217546 LAURUS
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 207099 RISING
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 206943 STRIDES PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 077261 TARO
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 213603 ZHEJIANG YONGTAI
NEURONTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription Yes AB 020235 VIATRIS
Back to Top