ANDA 219800, held by Granules Pharmaceuticals Inc. Amphetamine.
As of Nov 14, 2026, ANDA 219800 (Amphetamine), held by Granules Pharmaceuticals Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2025 | Original application | Tentative approval | None posted |
| Amphetamine3.1MG · tablet, orally disintegrating;oral | Amphetamine | None (tentative approval) |
| Amphetamine6.3MG · tablet, orally disintegrating;oral | Amphetamine | None (tentative approval) |
| Amphetamine9.4MG · tablet, orally disintegrating;oral | Amphetamine | None (tentative approval) |
| Amphetamine12.5MG · tablet, orally disintegrating;oral | Amphetamine | None (tentative approval) |
| Amphetamine15.7MG · tablet, orally disintegrating;oral | Amphetamine | None (tentative approval) |
| Amphetamine18.8MG · tablet, orally disintegrating;oral | 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
