Prozac

NDA 20101, held by Lilly. Fluoxetine Hydrochloride.

As of Nov 14, 2026, NDA 20101 (Prozac), held by Lilly, was first approved by FDA on Apr 24, 1991, with 30 approved supplements and 0 published complete response letters.

First approved: Apr 24, 1991
Review: Priority
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


Jul 29, 2002	Supplement 27Efficacy (new indication or use) · Priority review	Approved	None posted
Apr 24, 1991	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ProzacEQ 20MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Fluoxetine Hydrochloride	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


Jan 30, 2009	Supplement 42Labeling · Priority review	Approved	Label Letter
Mar 21, 2008	Supplement 39Labeling · Priority review	Approved	Letter Label
Mar 9, 2008	Supplement 38Labeling · Priority review	Approved	Label Letter
Aug 2, 2007	Supplement 37Labeling · Priority review	Approved	Letter Label
Mar 15, 2007	Supplement 36Labeling · Priority review	Approved	Letter
Sep 20, 2006	Supplement 35Labeling · Priority review	Approved	Label
Apr 11, 2006	Supplement 34Labeling · Priority review	Approved	Letter
Dec 1, 2005	Supplement 32Labeling · Priority review	Approved	Letter
Feb 18, 2005	Supplement 33Labeling · Priority review	Approved	Letter
Aug 19, 2004	Supplement 31Labeling · Priority review	Approved	Letter
May 25, 2004	Supplement 29Manufacturing · Priority review	Approved	Letter
Jul 29, 2002	Supplement 27Efficacy (new indication or use) · Priority review	Approved	None posted
Oct 7, 1999	Supplement 24Labeling · Priority review	Approved	Review
Jun 16, 1999	Supplement 26Labeling · Priority review	Approved	None posted
Aug 4, 1998	Supplement 23Manufacturing · Priority review	Approved	None posted
Aug 4, 1998	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 23, 1998	Supplement 20Manufacturing · Priority review	Approved	None posted
Mar 13, 1998	Supplement 21Labeling · Priority review	Approved	None posted
Mar 25, 1997	Supplement 9Labeling · Priority review	Approved	None posted
Apr 1, 1996	Supplement 14Manufacturing · Priority review	Approved	None posted
Sep 12, 1995	Supplement 12Labeling · Priority review	Approved	None posted
Sep 12, 1995	Supplement 11Labeling · Priority review	Approved	None posted
May 22, 1995	Supplement 6Manufacturing · Priority review	Approved	None posted
Mar 1, 1995	Supplement 10Labeling · Priority review	Approved	None posted
Jul 6, 1994	Supplement 7Labeling · Priority review	Approved	None posted
Aug 18, 1993	Supplement 4Labeling · Priority review	Approved	None posted
Mar 25, 1993	Supplement 5Labeling · Priority review	Approved	None posted
Aug 20, 1992	Supplement 3Labeling · Priority review	Approved	None posted
Jan 21, 1992	Supplement 2Labeling · Priority review	Approved	None posted
Jan 21, 1992	Supplement 1Labeling · Priority review	Approved	None posted
Apr 24, 1991	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20101
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