ANDA 213612, held by Epic Pharma LLC. Paroxetine Hydrochloride.
As of Nov 15, 2026, ANDA 213612 (Paroxetine Hydrochloride), held by Epic Pharma LLC, was first approved by FDA on Aug 11, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2021 | Original application | Approved | None posted |
| Paroxetine HydrochlorideEQ 12.5MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Discontinued |
| Paroxetine HydrochlorideEQ 25MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Discontinued |
| Paroxetine HydrochlorideEQ 37.5MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Discontinued |
| May 26, 2022 | Supplement 1Manufacturing | Approved | None posted |
| Aug 11, 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
