Treats Major Depressive Disorder (MDD). ANDA 210935, held by Sciegen Pharms. Fluoxetine Hydrochloride.
As of Nov 15, 2026, ANDA 210935 (Fluoxetine Hydrochloride), held by Sciegen Pharms, was first approved by FDA on Mar 20, 2019, with 3 approved supplements and 0 published complete response letters.
Fluoxetine is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients age 8 to 18 years Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years Acute and maintenance treatment of Bulimia Nervosa in adult patients Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients 1.1 Major Depressive Disorder Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2019 | Original application | Approved | None posted |
| Fluoxetine HydrochlorideEQ 10MG BASE · tablet;oral | Fluoxetine Hydrochloride | Rx |
| Fluoxetine HydrochlorideEQ 20MG BASE · tablet;oral | Fluoxetine Hydrochloride | Rx |
| Jun 17, 2026 | Supplement 11Manufacturing | Approved | None posted |
| Aug 18, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 21, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 20, 2019 | Original application | Approved | None posted |
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
