Manages postherpetic neuralgia. ANDA 78974, held by Mission Pharmacal. Gabapentin.
As of Nov 14, 2026, ANDA 78974 (Gabapentin), held by Mission Pharmacal, was first approved by FDA on Feb 18, 2011, with 6 approved supplements and 0 published complete response letters.
Gabapentin oral solution is indicated for: Management of postherpetic neuralgia in adults Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy Gabapentin is indicated for: Postherpetic neuralgia in adults Adjuncttive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 2011 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gabapentin250MG/5ML · solution;oral | Gabapentin | Rx |
| Jun 20, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 20, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 20, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| May 8, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 8, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 22, 2015 | Supplement 2Manufacturing | Approved | None posted |
| Feb 18, 2011 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
