Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 076672
Company: TARO
Company: TARO
| 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 |
|---|---|---|---|---|---|---|---|
| 07/03/2013 | ORIG-1 | Approval |
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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