ANDA 74803, held by Barr. Fluoxetine Hydrochloride.
As of Nov 15, 2026, ANDA 74803 (Fluoxetine Hydrochloride), held by Barr, was first approved by FDA on Aug 2, 2001, with 18 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2001 | Original application | Approved |
| Fluoxetine HydrochlorideEQ 20MG BASE · capsule;oral | Fluoxetine Hydrochloride | Discontinued |
| Fluoxetine HydrochlorideEQ 10MG BASE · capsule;oral | Fluoxetine Hydrochloride | Discontinued |
| May 24, 2010 | Supplement 23Labeling | Approved | None posted |
| Jul 14, 2009 | Supplement 22Labeling | Approved | None posted |
| Sep 25, 2008 | Supplement 21Labeling | Approved | None posted |
| Mar 17, 2008 | Supplement 19Labeling | Approved | None posted |
| Mar 17, 2008 | Supplement 18Labeling | Approved | None posted |
| Aug 25, 2005 | Supplement 16Labeling | Approved | None posted |
| Aug 25, 2005 | Supplement 14Labeling | Approved | None posted |
| Nov 26, 2003 | Supplement 11Labeling | Approved | None posted |
| Nov 26, 2002 | Supplement 10Manufacturing | Approved | None posted |
| Jan 30, 2002 | Supplement 9Manufacturing | Approved | |
| Jan 30, 2002 | Supplement 8Manufacturing | Approved | |
| Jan 30, 2002 | Supplement 7Manufacturing | Approved | |
| Jan 30, 2002 | Supplement 6Manufacturing | Approved | |
| Jan 30, 2002 | Supplement 5Manufacturing | Approved | |
| Jan 30, 2002 | Supplement 4Labeling | Approved | |
| Dec 13, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Dec 13, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Dec 13, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Aug 2, 2001 | Original application | 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
