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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214956
Company: ASCENT PHARMS INC
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
05/10/2021 ORIG-1 Approval STANDARD

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
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 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 206943 ACI
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 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 206943 ACI
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 VIATRIS
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