NDA 21860, held by Apil. Fluoxetine Hydrochloride.
As of Nov 14, 2026, NDA 21860 (Sarafem), held by Apil, was first approved by FDA on May 19, 2006, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 2006 | Original applicationNew dosage form · Standard review | Approved |
| SarafemEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| SarafemEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| SarafemEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Fluoxetine Hydrochloride | DiscontinuedReference drug |
| Sep 20, 2021 | Supplement 15Labeling · Standard review | Approved | |
| Jan 4, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Dec 1, 2014 | Supplement 10Labeling · Standard review | Approved | |
| Jul 5, 2013 | Supplement 6Labeling · Standard review | Approved | |
| Jul 5, 2013 | Supplement 7Labeling · Standard review | Approved | |
| Jul 5, 2013 | Supplement 8Labeling | Approved | |
| Jul 5, 2013 | Supplement 9Labeling | Approved | |
| Apr 22, 2009 | Supplement 5Labeling · Standard review | Approved | |
| Nov 30, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Apr 5, 2007 | Supplement 1Labeling · Standard review | Approved | |
| May 19, 2006 | 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
