Fluoxetine Hydrochloride

Treats Major Depressive Disorder. ANDA 77849, held by Lannett Co Inc. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 77849 (Fluoxetine Hydrochloride), held by Lannett Co Inc, was first approved by FDA on Feb 9, 2007, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 9, 2007
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fluoxetine oral solution 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 oral solution monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Feb 9, 2007	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fluoxetine HydrochlorideEQ 20MG BASE/5ML · solution;oral	Fluoxetine Hydrochloride	Rx

All 13 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Sep 21, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Sep 7, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Sep 7, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Jan 4, 2017	Supplement 10Labeling · Standard review	Approved	None posted
Dec 27, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Jul 18, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Jul 16, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Mar 11, 2009	Supplement 3Labeling	Approved	None posted
Mar 11, 2009	Supplement 4Labeling	Approved	None posted
May 29, 2008	Supplement 2Labeling	Approved	None posted
Oct 10, 2007	Supplement 1Labeling	Approved	None posted
Feb 9, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77849
Drugs@FDA: Overview at FDA
Company: Lannett Company

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