Application 020083

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPORANOX	ITRACONAZOLE	CAPSULE;ORAL	100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020083-001	SPORANOX	ITRACONAZOLE	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020083-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020083-001	SPORANOX	100MG	CAPSULE / ORAL	AB	RLD, RS	1992-09-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020083-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020083-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020083-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020083-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020083-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020083-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020083-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020083-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020083-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020083-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020083-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020083-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020083-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020083-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020083-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020083-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020083-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020083-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020083-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020083-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020083-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020083-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020083-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020083-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020083-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020083-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020083-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020083-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020083-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020083-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020083-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020083-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020083-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020083-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020083-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020083-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020083-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020083-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020083-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020083-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPORANOX	ITRACONAZOLE	Janssen Pharmaceuticals, Inc.	a4d555fa-787c-40fb-bb7d-b0d4f7318fd0	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020083 application number: NDA020083 ndc (product): 50458-290
itraconazole	ITRACONAZOLE	Patriot Pharmaceuticals	6242b7ad-eaa0-a524-b6e0-ec33e63407db	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020083 application number: NDA020083 ndc (product): 10147-1700

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10147-1700	itraconazole	ITRACONAZOLE	Patriot Pharmaceuticals	NDA	Current
10147-1700	itraconazole	ITRACONAZOLE	Patriot Pharmaceuticals	NDA	Current
10147-1700	itraconazole	ITRACONAZOLE	Patriot Pharmaceuticals	NDA	Current
10147-1700	itraconazole	ITRACONAZOLE	Patriot Pharmaceuticals	NDA	Current
10147-1700	itraconazole	ITRACONAZOLE	Patriot Pharmaceuticals	NDA	Current
10147-1700	itraconazole	ITRACONAZOLE	Patriot Pharmaceuticals	NDA	Current
50458-290	SPORANOX	ITRACONAZOLE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-290	SPORANOX	ITRACONAZOLE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-290	SPORANOX	ITRACONAZOLE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-290	SPORANOX	ITRACONAZOLE	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-290	SPORANOX	ITRACONAZOLE	Janssen Pharmaceuticals, Inc.	NDA	Current
68151-2718	itraconazole	ITRACONAZOLE	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80679	SUPPL	2024-12-23
80671	SUPPL	2024-12-20
80670	SUPPL	2024-12-20
80030	SUPPL	2024-10-29
80021	SUPPL	2024-10-28
77409	SUPPL	2024-02-07
77405	SUPPL	2024-02-06
75905	SUPPL	2023-10-24
75881	SUPPL	2023-10-20
72809	SUPPL	2022-12-07
72797	SUPPL	2022-12-06
57947	SUPPL	2019-03-11
57945	SUPPL	2019-03-11
54077	SUPPL	2018-05-10
54062	SUPPL	2018-05-10
50033	SUPPL	2017-10-12
49991	SUPPL	2017-10-10
47696	SUPPL	2017-03-24
47659	SUPPL	2017-03-23
34250	SUPPL	2015-04-17
21134	SUPPL	2015-04-17
2003	SUPPL	2014-06-11
12198	SUPPL	2014-06-10
21133	SUPPL	2012-04-23
21132	SUPPL	2012-04-23
2002	SUPPL	2012-04-23
34249	SUPPL	2012-04-20
12197	SUPPL	2012-04-20
12196	SUPPL	2012-04-20
2001	SUPPL	2010-08-03
12195	SUPPL	2010-07-31
34248	SUPPL	2009-03-17
34247	SUPPL	2009-03-17
12194	SUPPL	2009-03-17
21131	SUPPL	2009-03-10
21130	SUPPL	2009-03-10
2000	SUPPL	2009-03-10
34246	SUPPL	2004-07-21
12193	SUPPL	2004-07-21
1999	SUPPL	2004-07-21
1998	SUPPL	2004-07-21
34245	SUPPL	2003-12-02
21129	SUPPL	2003-11-25
34244	SUPPL	2003-04-24
21128	SUPPL	2002-07-17
21126	SUPPL	2002-07-17
12192	SUPPL	2002-07-17
12190	SUPPL	2002-07-17
21127	SUPPL	2002-04-11
12191	SUPPL	2002-04-11