Prozac Weekly

NDA 21235, held by Lilly. Fluoxetine Hydrochloride.

As of Nov 14, 2026, NDA 21235 (Prozac Weekly), held by Lilly, was first approved by FDA on Feb 26, 2001, with 21 approved supplements and 0 published complete response letters.

First approved: Feb 26, 2001
Review: Standard
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Feb 26, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prozac WeeklyEQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule, delayed rel pellets;oral	Fluoxetine Hydrochloride	DiscontinuedReference drug

All 22 submissions, including labeling and manufacturing supplements


Mar 24, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label Medication Guide
Jan 4, 2017	Supplement 26Labeling	Approved	Letter Label
Aug 4, 2015	Supplement 25Labeling · Standard review	Approved	Label Letter
Jul 18, 2014	Supplement 24Labeling	Approved	Letter Label
Jul 26, 2013	Supplement 21Labeling	Approved	Label Letter
Jan 3, 2013	Supplement 19Labeling · Standard review	Approved	Label Letter
Jan 3, 2013	Supplement 20Labeling · Standard review	Approved	Letter Label
Jun 15, 2011	Supplement 18Labeling · Standard review	Approved	Review Letter Label
Apr 4, 2011	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 4, 2011	Supplement 16Labeling	Approved	Review Letter Label
Apr 4, 2011	Supplement 17Labeling	Approved	Letter Label
Jan 30, 2009	Supplement 14Labeling	Approved	Label Letter
Mar 21, 2008	Supplement 11Labeling · Standard review	Approved	Label Letter
Mar 9, 2008	Supplement 10Labeling · Standard review	Approved	Label Letter
Aug 2, 2007	Supplement 9Labeling · Standard review	Approved	Letter Label
Mar 15, 2007	Supplement 8Labeling · Standard review	Approved	Letter
Sep 20, 2006	Supplement 7Labeling · Standard review	Approved	Label
Apr 11, 2006	Supplement 6Labeling · Standard review	Approved	Letter
Dec 1, 2005	Supplement 3Labeling · Standard review	Approved	Letter
Feb 18, 2005	Supplement 4Labeling · Standard review	Approved	Letter
Aug 19, 2004	Supplement 2Labeling · Standard review	Approved	Letter
Feb 26, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21235
Drugs@FDA: Overview at FDA
Company: Lilly

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