ANDA 212191, held by G And W Labs Inc. Fluoxetine Hydrochloride.
As of Nov 15, 2026, ANDA 212191 (Fluoxetine Hydrochloride), held by G And W Labs Inc, was first approved by FDA on Jul 5, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluoxetine HydrochlorideEQ 60MG BASE ยท tablet;oral | Fluoxetine 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
