Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078974
Company: MISSION PHARMACAL
Company: MISSION PHARMACAL
| 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 |
|---|---|---|---|---|---|
| 06/20/2024 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/20/2024 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/20/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2015 | SUPPL-4 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
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-Container/Carton Labels, Labeling-Medication Guide |
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 | 091286 | AJENAT PHARMS |
| 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 | 078974 | MISSION PHARMACAL |
| GABAPENTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 211330 | PAI HOLDINGS PHARM |
| GABAPENTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 216492 | RUBICON RESEARCH |
| NEURONTIN | GABAPENTIN | 250MG/5ML | SOLUTION;ORAL | Prescription | Yes | AA | 021129 | VIATRIS |