Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075350
Company: ACTAVIS ELIZABETH
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
09/12/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075350_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2021 SUPPL-67 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/21/2020 SUPPL-66 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/21/2020 SUPPL-60 Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/13/2016 SUPPL-57 Labeling-Package Insert

Label is not available on this site.

03/16/2015 SUPPL-54 Labeling-Package Insert

Label is not available on this site.

01/13/2016 SUPPL-49 Labeling-Package Insert

Label is not available on this site.

04/11/2012 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

08/28/2012 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

06/24/2011 SUPPL-28 REMS-Proposal, Labeling-Package Insert

Label is not available on this site.

05/13/2010 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

12/05/2006 SUPPL-14 Labeling

Label is not available on this site.

12/23/2005 SUPPL-9 Labeling

Label is not available on this site.

04/08/2005 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 206943 ACI HEALTHCARE LTD
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 LTD
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 207099 GRAVITI PHARMS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 077242 SUN PHARM INDS LTD
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 UPJOHN

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 206943 ACI HEALTHCARE LTD
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 LTD
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 207099 GRAVITI PHARMS
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 077242 SUN PHARM INDS LTD
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 UPJOHN

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 206943 ACI HEALTHCARE LTD
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 LTD
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 207099 GRAVITI PHARMS
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 204989 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 211314 STRIDES PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 077242 SUN PHARM INDS LTD
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 UPJOHN

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