Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091286
Company: BELCHER
Company: BELCHER
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 |
---|---|---|---|---|---|---|---|
03/14/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/07/2023 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/07/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
08/07/2023 | SUPPL-3 | 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 | 217682 | ANNORA PHARMA |
GABAPENTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 091286 | BELCHER |
GABAPENTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 078974 | MISSION PHARMACAL |
GABAPENTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 216492 | RUBICON |
GABAPENTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 076672 | TARO |
NEURONTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 021129 | VIATRIS |