ANDA 215003, held by Novitium Pharma. Paroxetine Hydrochloride.
As of Nov 15, 2026, ANDA 215003 (Paroxetine Hydrochloride), held by Novitium Pharma, was first approved by FDA on Sep 3, 2021, with 2 approved supplements and 0 published complete response letters.
Paroxetine is indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD) Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of: Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paroxetine HydrochlorideEQ 10MG BASE/5ML · suspension;oral | Paroxetine Hydrochloride | Rx |
| Jan 19, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 31, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 3, 2021 | 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
