Treats Major Depressive Disorder (MDD). ANDA 213286, held by Aurobindo Pharma Ltd. Fluoxetine Hydrochloride.
As of Nov 15, 2026, ANDA 213286 (Fluoxetine Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Apr 8, 2020, 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 aged 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 tablets are 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 |
|---|---|---|---|
| Apr 8, 2020 | Original application | Approved | None posted |
| Fluoxetine HydrochlorideEQ 10MG BASE · tablet;oral | Fluoxetine Hydrochloride | Rx |
| Fluoxetine HydrochlorideEQ 20MG BASE · tablet;oral | Fluoxetine Hydrochloride | Rx |
| Jan 15, 2026 | Supplement 6Manufacturing | Approved | None posted |
| Aug 18, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 20, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 8, 2020 | 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
