Treats Major Depressive Disorder. ANDA 216953, held by Upsher Smith Labs. Fluoxetine Hydrochloride.
As of Nov 15, 2026, ANDA 216953 (Fluoxetine Hydrochloride), held by Upsher Smith Labs, was first approved by FDA on Nov 15, 2022, with 1 approved supplement and 0 published complete response letters.
Fluoxetine is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. Acute treatment of Panic Disorder, with or without agoraphobia. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluoxetine HydrochlorideEQ 20MG BASE/5ML · solution;oral | Fluoxetine Hydrochloride | Rx |
| Aug 18, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 15, 2022 | 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
