Fluoxetine Hydrochloride

ANDA 75049, held by Pharmazone. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 75049 (Fluoxetine Hydrochloride), held by Pharmazone, was first approved by FDA on Aug 2, 2001, with 26 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2001
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
Aug 2, 2001	Original application	Approved	Letter Label Review

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 27 submissions, including labeling and manufacturing supplements


Sep 28, 2020	Supplement 42Labeling · Standard review	Approved	None posted
Sep 28, 2020	Supplement 40Labeling · Standard review	Approved	None posted
Sep 28, 2020	Supplement 39Labeling · Standard review	Approved	None posted
Sep 28, 2020	Supplement 36Labeling · Standard review	Approved	None posted
Sep 28, 2020	Supplement 35Labeling · Standard review	Approved	None posted
Aug 9, 2010	Supplement 32Labeling	Approved	None posted
Aug 21, 2009	Supplement 30Labeling	Approved	None posted
Oct 21, 2008	Supplement 27Labeling	Approved	None posted
Nov 7, 2007	Supplement 23Labeling	Approved	None posted
Nov 7, 2007	Supplement 21Labeling	Approved	None posted
Nov 6, 2006	Supplement 20Labeling	Approved	None posted
Jan 31, 2006	Supplement 19Labeling	Approved	None posted
Jun 9, 2005	Supplement 17Labeling	Approved	None posted
Jun 9, 2005	Supplement 14Labeling	Approved	None posted
Sep 13, 2004	Supplement 13Labeling	Approved	None posted
Sep 13, 2004	Supplement 12Labeling	Approved	None posted
Nov 19, 2003	Supplement 11Labeling	Approved	None posted
Jan 29, 2002	Supplement 10Labeling	Approved	Letter
Jan 29, 2002	Supplement 9Manufacturing	Approved	Letter
Jan 29, 2002	Supplement 8Labeling	Approved	Letter
Jan 29, 2002	Supplement 7Manufacturing	Approved	Letter
Jan 29, 2002	Supplement 5Manufacturing	Approved	Letter
Jan 29, 2002	Supplement 4Manufacturing	Approved	Letter
Jan 29, 2002	Supplement 3Labeling	Approved	Letter
Jan 29, 2002	Supplement 2Manufacturing	Approved	Letter
Aug 22, 2001	Supplement 1Labeling	Approved	Letter
Aug 2, 2001	Original application	Approved	Letter Label Review

Identifiers

Application: ANDA 75049
Drugs@FDA: Overview at FDA
Company: Pharmazone

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