ANDA 215675, held by Sciegen Pharms. Pregabalin.
As of Nov 14, 2026, ANDA 215675 (Pregabalin), held by Sciegen Pharms, was first approved by FDA on Sep 14, 2022, with 0 approved supplements and 0 published complete response letters.
Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 14, 2022 | Original application | Approved | None posted |
| Pregabalin82.5MG · tablet, extended release;oral | Pregabalin | Discontinued |
| Pregabalin165MG · tablet, extended release;oral | Pregabalin | Discontinued |
| Pregabalin330MG · tablet, extended release;oral | Pregabalin | Discontinued |
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
