Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077242
Company: SUN PHARM INDS LTD
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
08/24/2006 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
09/10/2015 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/30/2011 SUPPL-10 REMS-Proposal

Label is not available on this site.

03/30/2011 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/13/2010 SUPPL-7 Labeling-Container/Carton Labels

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 075360 APOTEX INC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
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 PHARM
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER PHARMS

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 075360 APOTEX INC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
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 PHARM
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER PHARMS

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 075360 APOTEX INC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
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 PHARM
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER PHARMS

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