ANDA 78026, held by Roxane. Paroxetine Hydrochloride.
As of Nov 15, 2026, ANDA 78026 (Paroxetine Hydrochloride), held by Roxane, was first approved by FDA on Jun 29, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2007 | Original application | Approved | None posted |
| Paroxetine HydrochlorideEQ 10MG BASE · tablet;oral | Paroxetine Hydrochloride | Discontinued |
| Paroxetine HydrochlorideEQ 20MG BASE · tablet;oral | Paroxetine Hydrochloride | Discontinued |
| Paroxetine HydrochlorideEQ 30MG BASE · tablet;oral | Paroxetine Hydrochloride | Discontinued |
| Paroxetine HydrochlorideEQ 40MG BASE · tablet;oral | Paroxetine Hydrochloride | Discontinued |
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
