Fluoxetine Hydrochloride

ANDA 77469, held by Sandoz. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 77469 (Fluoxetine Hydrochloride), held by Sandoz, was first approved by FDA on Nov 17, 2008, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 17, 2008
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 17, 2008	Original application	Approved	None posted

Products

2 strengths and forms


Fluoxetine HydrochlorideEQ 10MG BASE · capsule;oral	Fluoxetine Hydrochloride	Discontinued
Fluoxetine HydrochlorideEQ 20MG BASE · capsule;oral	Fluoxetine Hydrochloride	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Aug 15, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Aug 15, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Jan 4, 2017	Supplement 13Labeling · Standard review	Approved	None posted
May 5, 2016	Supplement 12Labeling · Standard review	Approved	None posted
Jul 31, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Dec 15, 2009	Supplement 5Labeling	Approved	None posted
Dec 15, 2009	Supplement 2Labeling	Approved	None posted
Nov 17, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 77469
Drugs@FDA: Overview at FDA
Company: Sandoz

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