Manages postherpetic neuralgia. ANDA 76403, held by Acella Pharms LLC. Gabapentin.
As of Nov 14, 2026, ANDA 76403 (Gabapentin), held by Acella Pharms LLC, was first approved by FDA on May 1, 2012, with 1 approved supplement 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 Oral Solution is indicated for: 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
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gabapentin250MG/5ML · solution;oral | Gabapentin | Rx |
| Jun 8, 2017 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 1, 2012 | Original application | Approved | None posted |
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
