Sporanox

NDA 20083, held by Janssen Pharms. Itraconazole.

As of Nov 14, 2026, NDA 20083 (Sporanox), held by Janssen Pharms, was first approved by FDA on Sep 11, 1992, with 52 approved supplements and 0 published complete response letters.

First approved: Sep 11, 1992
Review: Priority
Supplements approved: 52
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Itraconazole Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 53 submissions below


Mar 29, 1994	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 11, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sporanox100MG · capsule;oral	Itraconazole	RxReference drug

All 53 submissions, including labeling and manufacturing supplements


Jul 7, 2026	Supplement 72Labeling · Standard review	Approved	Label Letter
Dec 19, 2024	Supplement 70Labeling · Standard review	Approved	Label Letter Letter
Oct 25, 2024	Supplement 71Labeling · Standard review	Approved	Letter Label
Feb 5, 2024	Supplement 68Labeling · Standard review	Approved	Letter Label
Oct 19, 2023	Supplement 67Labeling · Standard review	Approved	Label Letter
Dec 5, 2022	Supplement 65Labeling · Standard review	Approved	Label Letter
Mar 8, 2019	Supplement 63Labeling · Standard review	Approved	Letter Label
May 8, 2018	Supplement 62Labeling · Standard review	Approved	Label Letter
Oct 7, 2017	Supplement 61Labeling · Standard review	Approved	Letter Label
Mar 17, 2017	Supplement 60Labeling · Standard review	Approved	Letter Label
Apr 16, 2015	Supplement 58Labeling · Standard review	Approved	Letter Label
Jun 13, 2014	Supplement 55Manufacturing	Approved	None posted
Jun 9, 2014	Supplement 53Labeling · Standard review	Approved	Letter Label
Apr 11, 2014	Supplement 54Manufacturing	Approved	None posted
Jun 5, 2013	Supplement 52Manufacturing	Approved	None posted
Mar 1, 2013	Supplement 51Manufacturing	Approved	None posted
Apr 18, 2012	Supplement 50Labeling · Standard review	Approved	Letter Label
Apr 18, 2012	Supplement 49Labeling · Standard review	Approved	Letter Label
Apr 18, 2012	Supplement 48Labeling	Approved	Letter Label
Jul 29, 2010	Supplement 46Labeling	Approved	Letter Label
Mar 5, 2009	Supplement 44Labeling · Standard review	Approved	Label Letter
Mar 5, 2009	Supplement 41Labeling · Standard review	Approved	Label Letter
Mar 5, 2009	Supplement 40Labeling · Standard review	Approved	Label Letter
Jul 14, 2004	Supplement 35Labeling · Standard review	Approved	Letter Label
Jul 14, 2004	Supplement 34Labeling · Standard review	Approved	Letter Label
Nov 10, 2003	Supplement 33Labeling · Standard review	Approved	Label Letter
Oct 10, 2002	Supplement 30Manufacturing	Approved	None posted
Jul 17, 2002	Supplement 31Labeling · Standard review	Approved	Label Letter
Jul 17, 2002	Supplement 28Labeling · Standard review	Approved	Label Letter
Apr 11, 2002	Supplement 29Labeling · Standard review	Approved	Label Letter
Feb 27, 2002	Supplement 27Manufacturing	Approved	None posted
May 9, 2001	Supplement 25Labeling · Standard review	Approved	Label
Mar 21, 2001	Supplement 26Manufacturing	Approved	None posted
Sep 29, 1999	Supplement 24Manufacturing	Approved	None posted
Feb 17, 1999	Supplement 23Manufacturing	Approved	None posted
Jul 27, 1998	Supplement 22Manufacturing	Approved	None posted
Jul 27, 1998	Supplement 21Manufacturing	Approved	None posted
Nov 3, 1997	Supplement 20Manufacturing	Approved	None posted
Aug 6, 1997	Supplement 19Labeling · Standard review	Approved	None posted
Aug 6, 1997	Supplement 18Labeling · Standard review	Approved	None posted
Dec 10, 1996	Supplement 17Labeling · Standard review	Approved	None posted
May 23, 1996	Supplement 12Labeling · Standard review	Approved	None posted
Mar 22, 1996	Supplement 16Manufacturing	Approved	None posted
Sep 15, 1995	Supplement 11Manufacturing	Approved	None posted
Sep 8, 1995	Supplement 9Manufacturing	Approved	None posted
Oct 12, 1994	Supplement 8Manufacturing	Approved	None posted
May 9, 1994	Supplement 5Manufacturing	Approved	None posted
Mar 29, 1994	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Nov 9, 1993	Supplement 6Labeling · Standard review	Approved	None posted
Jun 9, 1993	Supplement 3Manufacturing	Approved	None posted
Dec 28, 1992	Supplement 2Labeling · Standard review	Approved	None posted
Oct 13, 1992	Supplement 1Manufacturing	Approved	None posted
Sep 11, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Show all 53

Identifiers

Application: NDA 20083
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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