ANDA 207139, held by Actavis Labs Fl Inc. Paroxetine Mesylate.
As of Nov 15, 2026, ANDA 207139 (Paroxetine Mesylate), held by Actavis Labs Fl Inc, was first approved by FDA on Jun 20, 2017, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paroxetine MesylateEQ 7.5MG BASE · capsule;oral | Paroxetine Mesylate | Rx |
| Mar 18, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 25, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 20, 2017 | Original application | Approved |
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
