ANDA 209293, held by Sciecure Pharma Inc. Paroxetine Hydrochloride.
As of Nov 15, 2026, ANDA 209293 (Paroxetine Hydrochloride), held by Sciecure Pharma Inc, was first approved by FDA on Jun 12, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2018 | 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 |
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
