Fluoxetine Hydrochloride

ANDA 75464, held by Landela Pharm. Fluoxetine Hydrochloride.

As of Nov 15, 2026, ANDA 75464 (Fluoxetine Hydrochloride), held by Landela Pharm, 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	Letter

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jul 11, 2011	Supplement 6Labeling	Approved	None posted
May 31, 2011	Supplement 7Labeling	Approved	None posted
Jan 30, 2002	Original application	Approved	Letter

Identifiers

Application: ANDA 75464
Drugs@FDA: Overview at FDA
Company: Landela Pharm

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