Symbyax

NDA 21520, held by Lilly. Fluoxetine Hydrochloride; Olanzapine.

As of Nov 15, 2026, NDA 21520 (Symbyax), held by Lilly, was first approved by FDA on Dec 24, 2003, with 45 approved supplements and 0 published complete response letters.

First approved: Dec 24, 2003
Review: Priority
Supplements approved: 45
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 46 submissions below


Oct 10, 2014	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 26, 2013	Supplement 39Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Mar 19, 2009	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Review Label
Apr 9, 2007	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
Dec 24, 2003	Original applicationNew combination · Priority review	Approved	Review Patient Package Insert Label Letter

Products

5 strengths and forms


SymbyaxEQ 25MG BASE;EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Fluoxetine Hydrochloride; Olanzapine	DiscontinuedReference drug
SymbyaxEQ 25MG BASE;EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Fluoxetine Hydrochloride; Olanzapine	DiscontinuedReference drug
SymbyaxEQ 50MG BASE;EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Fluoxetine Hydrochloride; Olanzapine	DiscontinuedReference drug
SymbyaxEQ 25MG BASE;EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Fluoxetine Hydrochloride; Olanzapine	DiscontinuedReference drug
SymbyaxEQ 50MG BASE;EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Fluoxetine Hydrochloride; Olanzapine	DiscontinuedReference drug

All 46 submissions, including labeling and manufacturing supplements


Jan 22, 2025	Supplement 56Labeling · Standard review	Approved	Letter Label Medication Guide
Aug 18, 2023	Supplement 55Labeling · Standard review	Approved	Label Letter
Sep 20, 2021	Supplement 54Labeling	Approved	Label Letter
Mar 4, 2021	Supplement 52Labeling · Standard review	Approved	Label Letter
Oct 23, 2020	Supplement 51Labeling · Standard review	Approved	Letter Label
Apr 21, 2020	Supplement 53Labeling	Approved	Letter Label
Mar 27, 2018	Supplement 50Labeling · Standard review	Approved	Letter Label
Mar 24, 2017	Supplement 42Labeling · Standard review	Approved	Letter Label
Feb 23, 2017	Supplement 49Labeling · Standard review	Approved	Letter Label
Feb 23, 2017	Supplement 48Labeling	Approved	Letter
Jan 4, 2017	Supplement 47Labeling	Approved	Letter Label
Oct 6, 2016	Supplement 46Labeling	Approved	Label Letter
Dec 19, 2014	Supplement 34Labeling · Standard review	Approved	Label Letter
Oct 30, 2014	Supplement 43Manufacturing · Priority review	Approved	None posted
Oct 10, 2014	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 18, 2014	Supplement 45Labeling	Approved	Letter Label
Aug 7, 2013	Supplement 40Labeling · Standard review	Approved	Label Letter
Jul 26, 2013	Supplement 39Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jul 26, 2013	Supplement 37Labeling	Approved	Letter Label
Jan 3, 2013	Supplement 36Labeling · Standard review	Approved	Letter Label
Jan 3, 2013	Supplement 35Labeling · Standard review	Approved	Letter Label
Aug 8, 2012	Supplement 38Labeling · Standard review	Approved	Letter Label
Oct 4, 2011	Supplement 33Labeling	Approved	Letter Label
Jun 21, 2011	Supplement 32REMS	Approved	Label Letter
Jun 21, 2011	Supplement 31REMS	Approved	Label Letter
Apr 22, 2011	Supplement 28Labeling	Approved	Label Letter
Apr 22, 2011	Supplement 25Labeling	Approved	Label Letter
Dec 1, 2010	Supplement 29Labeling	Approved	Letter Label
Dec 1, 2010	Supplement 27Labeling	Approved	Letter Label
Jan 27, 2010	Supplement 23Labeling	Approved	Letter Label
Aug 31, 2009	Supplement 22Labeling	Approved	Label
Mar 19, 2009	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Review Label
Aug 14, 2008	Supplement 20Labeling · Standard review	Approved	Letter
Mar 21, 2008	Supplement 17Labeling · Standard review	Approved	Letter Label
Mar 18, 2008	Supplement 16Labeling · Standard review	Approved	Letter Label
Aug 2, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
Aug 2, 2007	Supplement 13Labeling · Standard review	Approved	Letter Label
Apr 9, 2007	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
Apr 9, 2007	Supplement 8Labeling · Standard review	Approved	Letter Label
Nov 29, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Sep 20, 2006	Supplement 11Labeling · Standard review	Approved	Label
Jul 3, 2006	Supplement 7Labeling · Standard review	Approved	None posted
Jul 3, 2006	Supplement 6Labeling · Priority review	Approved	None posted
Jul 3, 2006	Supplement 3Labeling · Priority review	Approved	None posted
Feb 18, 2005	Supplement 5Labeling · Standard review	Approved	Letter
Dec 24, 2003	Original applicationNew combination · Priority review	Approved	Review Patient Package Insert Label Letter

Identifiers

Application: NDA 21520
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