Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078974
Company: HI TECH PHARMA
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
02/18/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078974s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/08/2015 SUPPL-4 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/08/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/22/2015 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

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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