ANDA 213485, held by Cspc Ouyi. Paroxetine Hydrochloride.
As of Nov 15, 2026, ANDA 213485 (Paroxetine Hydrochloride), held by Cspc Ouyi, was first approved by FDA on Feb 16, 2021, with 1 approved supplement and 0 published complete response letters.
Paroxetine extended-release tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Panic disorder (PD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Paroxetine extended-release tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of: Major Depressive Disorder (MDD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Premenstrual Dysphoric Disorder (PMDD)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 2021 | Original application | Approved | None posted |
| Paroxetine HydrochlorideEQ 12.5MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Rx |
| Paroxetine HydrochlorideEQ 25MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Rx |
| Paroxetine HydrochlorideEQ 37.5MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Rx |
| Jun 10, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 16, 2021 | 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
