Treats moderate to severe vasomotor symptoms (VMS) associated with menopause. ANDA 207188, held by Prinston. Paroxetine Mesylate.
As of Nov 15, 2026, ANDA 207188 (Paroxetine Mesylate), held by Prinston, was first approved by FDA on Aug 18, 2017, with 0 approved supplements and 0 published complete response letters.
Paroxetine capsules are indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitations of Use: Paroxetine capsules are not indicated for the treatment of any psychiatric condition. Paroxetine capsules have a lower recommended paroxetine dosage than that used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and effectiveness of the lower paroxetine capsules dosage have not been established for any psychiatric condition.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 18, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paroxetine MesylateEQ 7.5MG BASE · capsule;oral | Paroxetine Mesylate | 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
