ANDA 220284, held by Granules Pharmaceuticals Inc. Amphetamine.
As of Nov 14, 2026, ANDA 220284 (Amphetamine), held by Granules Pharmaceuticals Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 2026 | Original application | Tentative approval |
| Amphetamine10MG · tablet, extended release | Amphetamine | None (tentative approval) |
| Amphetamine15MG · tablet, extended release | Amphetamine | None (tentative approval) |
| Amphetamine20MG · tablet, extended release | Amphetamine | None (tentative approval) |
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
