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FDA NDA · NDA021427

CYMBALTA

duloxetine hydrochloride

Sponsor: LILLY

APPLICATION
NDA021427
TYPE
NDA
ORIGINAL APPROVAL
2004-08-03
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued

Products

CYMBALTA · ReferenceDiscontinued
DULOXETINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
CYMBALTA · ReferenceDiscontinued
DULOXETINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL
CYMBALTA · ReferenceDiscontinued
DULOXETINE HYDROCHLORIDE EQ 60MG BASE · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2023-08-18Labeling · Supplement 57 · standard — Label ↗AP
2023-08-18Labeling · Supplement 55 · standard — Label ↗AP
2021-09-20Labeling · Supplement 56 · 901 required — Letter ↗AP
2020-10-01Labeling · Supplement 53 · standard — Letter ↗AP
2020-04-20Efficacy · Supplement 52 · standard — Label ↗AP
2019-10-04Labeling · Supplement 51 · standard — Label ↗AP
2017-12-19Labeling · Supplement 50 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 49 · 901 required — Label ↗AP
2016-09-02Labeling · Supplement 48 · 901 required — Label ↗AP
2016-07-12Manufacturing (CMC) · Supplement 47 · standardAP
2015-06-18Labeling · Supplement 46 · standard — Letter ↗AP
2014-11-25Labeling · Supplement 42 · standard — Label ↗AP
2014-11-25Labeling · Supplement 37 · standard — Letter ↗AP
2014-10-16Efficacy · Supplement 44 · standard — Letter ↗AP
2014-10-16Efficacy · Supplement 43 · standard — Letter ↗AP
2014-07-17Labeling · Supplement 45 · 901 required — Label ↗AP
2012-10-18Labeling · Supplement 40 · standard — Label ↗AP
2012-10-18Efficacy · Supplement 41 · priority — Pediatric Written Request ↗AP
2012-08-24Labeling · Supplement 38 · standard — Letter ↗AP
2012-08-24Labeling · Supplement 32 · standard — Letter ↗AP
2011-09-02Labeling · Supplement 39 · 901 required — Label ↗AP
2011-04-12Labeling · Supplement 36 · standard — Label ↗AP
2011-03-04Labeling · Supplement 31 · standard — Label ↗AP
2009-11-19Efficacy · Supplement 30 · standard — Label ↗AP
2009-03-18Labeling · Supplement 21 · standard — Label ↗AP
2009-03-18Labeling · Supplement 28 · standard — Label ↗AP
2009-03-18Labeling · Supplement 27 · standard — Letter ↗AP
2009-01-30Labeling · Supplement 29 · 901 required — Label ↗AP
2007-11-28Efficacy · Supplement 15 · unknown — Review ↗AP
2007-11-28Labeling · Supplement 17 · standard — Label ↗AP
2007-08-02Labeling · Supplement 18 · standard — Label ↗AP
2007-02-23Labeling · Supplement 13 · standard — Letter ↗AP
2007-02-23Efficacy · Supplement 11 · unknown — Letter ↗AP
2007-02-23Labeling · Supplement 9 · standard — Label ↗AP
2006-09-20Labeling · Supplement 12 · standard — Label ↗AP
2006-06-06Labeling · Supplement 7 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 2 · standard — Letter ↗AP
2004-08-03Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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