Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202024
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION;ORAL Prescription AA 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
03/23/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/08/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

GABAPENTIN

SOLUTION;ORAL; 250MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION;ORAL Prescription No AA 076403 ACELLA PHARMS LLC
GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION;ORAL Prescription No AA 202024 AMNEAL PHARMS
GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION;ORAL Prescription No AA 078974 HI TECH PHARMA
GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION;ORAL Prescription No AA 076672 TARO
GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION;ORAL Prescription No AA 091286 TRIS PHARMA INC
NEURONTIN GABAPENTIN 250MG/5ML SOLUTION;ORAL Prescription Yes AA 021129 PARKE DAVIS

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