Drugs@FDA: FDA-Approved Drugs
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 | 078974 | AKORN |
| GABAPENTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 202024 | AMNEAL PHARMS |
| 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 | VIATRIS |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English