U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207057
Company: CSPC OUYI

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
10/26/2017 ORIG-1 Approval STANDARD

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
Back to Top