Fluoxetine Hydrochloride

Treats Major Depressive Disorder. ANDA 90223, held by Alembic Pharms Ltd. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 90223 (Fluoxetine Hydrochloride), held by Alembic Pharms Ltd, was first approved by FDA on Mar 19, 2009, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 19, 2009
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE 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 and Olanzapine in Combination is indicated for the treatment of:
Acute treatment of depressive episodes associated with Bipolar I Disorder.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 19, 2009	Original application	Approved	None posted

Products

3 strengths and forms


Fluoxetine HydrochlorideEQ 10MG BASE · capsule;oral	Fluoxetine Hydrochloride	Rx
Fluoxetine HydrochlorideEQ 20MG BASE · capsule;oral	Fluoxetine Hydrochloride	Rx
Fluoxetine HydrochlorideEQ 40MG BASE · capsule;oral	Fluoxetine Hydrochloride	Rx

All 10 submissions, including labeling and manufacturing supplements


Dec 19, 2023	Supplement 31Labeling · Standard review	Approved	None posted
Dec 19, 2023	Supplement 29Labeling · Standard review	Approved	None posted
Jan 21, 2021	Supplement 25Labeling · Standard review	Approved	None posted
Jan 21, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Jan 12, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Jan 12, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Feb 28, 2012	Supplement 4Labeling	Approved	None posted
Feb 28, 2012	Supplement 3Labeling	Approved	None posted
Mar 22, 2010	Supplement 1Labeling	Approved	None posted
Mar 19, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90223
Drugs@FDA: Overview at FDA
Company: Alembic Pharmaceuticals

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