Fluoxetine Hydrochloride

Treats Major Depressive Disorder. ANDA 78619, held by Aurobindo Pharma. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 78619 (Fluoxetine Hydrochloride), held by Aurobindo Pharma, was first approved by FDA on Jan 31, 2008, with 18 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2008
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fluoxetine capsules are 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 capsules and Olanzapine in Combination are 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 19 submissions below

Date	Submission	Status	Documents
Jan 31, 2008	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 19 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 29Manufacturing	Approved	None posted
Mar 5, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Mar 5, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Mar 5, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Mar 5, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Mar 5, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Mar 5, 2024	Supplement 27Labeling · Standard review	Approved	None posted
Mar 5, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Mar 14, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Mar 14, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Mar 14, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Mar 14, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Feb 24, 2014	Supplement 5Manufacturing	Approved	None posted
Feb 28, 2012	Supplement 7Labeling	Approved	None posted
Jan 13, 2011	Supplement 4Manufacturing	Approved	None posted
Jun 25, 2010	Supplement 3Labeling	Approved	None posted
Mar 6, 2009	Supplement 2Labeling	Approved	None posted
Sep 25, 2008	Supplement 1Labeling	Approved	None posted
Jan 31, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78619
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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