NDA 202133, held by Twi Pharms. Fluoxetine Hydrochloride.
As of Nov 13, 2026, NDA 202133 (Fluoxetine Hydrochloride), held by Twi Pharms, was first approved by FDA on Oct 6, 2011, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 2011 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluoxetine HydrochlorideEQ 60MG BASE · tablet;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| Aug 18, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Aug 18, 2023 | Supplement 16Labeling · Standard review | Approved | |
| Sep 20, 2021 | Supplement 12Labeling | Approved | |
| Jan 4, 2017 | Supplement 4Labeling · Standard review | Approved | |
| Jan 4, 2017 | Supplement 5Labeling | Approved | |
| Jul 18, 2014 | Supplement 3Labeling | Approved | |
| Oct 6, 2011 | Original applicationNew dosage form · Standard review | Approved |
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
