Fluoxetine Hydrochloride

ANDA 76022, held by Carlsbad. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 76022 (Fluoxetine Hydrochloride), held by Carlsbad, was first approved by FDA on Jan 30, 2002, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 30, 2002
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 30, 2002	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 3 submissions, including labeling and manufacturing supplements


Jan 4, 2017	Supplement 4Labeling · Standard review	Approved	None posted
Feb 4, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Jan 30, 2002	Original application	Approved	None posted

Identifiers

Application: ANDA 76022
Drugs@FDA: Overview at FDA
Company: Carlsbad Technology

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