ANDA 219954, held by Annora Pharma. Paroxetine Hydrochloride.
As of Nov 15, 2026, ANDA 219954 (Paroxetine Hydrochloride), held by Annora Pharma, was first approved by FDA on Mar 5, 2026, with 0 approved supplements and 0 published complete response letters.
Paroxetine oral suspension is indicated in adults for the treatment of:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 5, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paroxetine HydrochlorideEQ 10MG BASE/5ML · suspension;oral | Paroxetine Hydrochloride | Rx |
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
