NDA 20974, held by Lilly. Fluoxetine Hydrochloride.
As of Nov 13, 2026, NDA 20974 (Prozac), held by Lilly, was first approved by FDA on Mar 9, 1999, with 8 approved supplements and 0 published complete response letters.
| Mar 13, 2009 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jul 29, 2002 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Mar 9, 1999 | Original applicationNew dosage form · Standard review | Approved |
| ProzacEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| ProzacEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| Mar 13, 2009 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 13, 2009 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 20, 2006 | Supplement 8Labeling · Standard review | Approved | |
| Apr 11, 2006 | Supplement 7Labeling · Standard review | Approved | |
| Dec 1, 2005 | Supplement 5Labeling · Standard review | Approved | |
| Feb 18, 2005 | Supplement 6Labeling · Standard review | Approved | |
| Aug 19, 2004 | Supplement 4Labeling · Standard review | Approved | |
| Jul 29, 2002 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Mar 9, 1999 | 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
