ANDA 217280, held by Alembic. Paroxetine Hydrochloride.
As of Nov 15, 2026, ANDA 217280 (Paroxetine Hydrochloride), held by Alembic, was first approved by FDA on Sep 24, 2025, with 1 approved supplement and 0 published complete response letters.
Paroxetine extended-release tablets are indicated in adults for the treatment of:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 24, 2025 | Original application | Approved | None posted |
| Paroxetine HydrochlorideEQ 25MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Rx |
| Paroxetine HydrochlorideEQ 37.5MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Rx |
| Paroxetine HydrochlorideEQ 12.5MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Rx |
| Mar 26, 2026 | Supplement 1Manufacturing | Approved | None posted |
| Sep 24, 2025 | 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
