Treats Major Depressive Disorder (MDD). ANDA 212684, held by Strides Pharma. Fluoxetine Hydrochloride.
As of Nov 15, 2026, ANDA 212684 (Fluoxetine Hydrochloride), held by Strides Pharma, was first approved by FDA on Apr 5, 2024, with 0 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 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 |
|---|---|---|---|
| Apr 5, 2024 | Original application | Approved | None posted |
| Fluoxetine HydrochlorideEQ 10MG BASE · tablet;oral | Fluoxetine Hydrochloride | Rx |
| Fluoxetine HydrochlorideEQ 20MG BASE · tablet;oral | Fluoxetine Hydrochloride | Rx |
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
