Application 020657

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPORANOX	ITRACONAZOLE	SOLUTION;ORAL	10MG/ML	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
N020657-001	SPORANOX	ITRACONAZOLE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1997-02-21

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	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL		RLD	1997-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL		RLD	1997-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020657-001	SPORANOX	10MG/ML	SOLUTION / ORAL	AA	RLD, RS	1997-02-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N020657-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020657-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020657-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020657-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020657-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020657-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020657-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020657-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020657-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020657-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020657-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020657-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020657-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020657-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020657-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020657-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020657-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020657-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020657-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020657-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020657-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020657-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020657-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020657-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020657-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020657-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020657-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020657-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020657-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020657-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020657-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020657-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020657-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020657-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020657-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020657-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020657-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020657-001	AA	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020657-001	6407079	2019-06-18	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020657-001	6407079	2019-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020657-001	6407079	2019-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020657-001	6407079	2019-06-18	`ea99ee380514…`

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 · 15 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	Name fallback brand name: SPORANOX generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	AvPAK	68165d90-953c-e2f5-e053-2a91aa0ada25	2026-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	Ascend Laboratories, LLC	349ffcf4-b2cd-4c93-9411-13c39275b8f3	2025-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Tolsura	ITRACONAZOLE	Mayne Pharma Commercial LLC	306352d1-9d5a-49ad-b72d-893b99546861	2025-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	American Health Packaging	e564067e-e469-4c51-9076-75f89f5c5cdf	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
ITRACONAZOLE	ITRACONAZOLE	Alembic Pharmaceuticals Inc.	23126370-8d6a-4027-bd8f-860e2776ba3a	2025-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	Camber Pharmaceuticals, Inc.	5af0b33d-bfa6-420b-86f0-067f95b402b2	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	Rising Pharma Holdings, Inc.	6df5ff94-47ba-4881-abb4-b321e35a6955	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
itraconazole	ITRACONAZOLE	Patriot Pharmaceuticals	6242b7ad-eaa0-a524-b6e0-ec33e63407db	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	Amneal Pharmaceuticals LLC	2ab38a8a-3708-4b97-9f7f-8e554a15348d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	Amneal Pharmaceuticals LLC	43ded1aa-f825-40fe-aa9a-addd36a07f06	2025-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	Torrent Pharmaceuticals Limited	b1274d78-1096-4ae3-8299-a2e94eaa0ea5	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	NorthStar RxLLC	46732a10-1f0d-4022-9689-256c44683e96	2023-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole Oral	ITRACONAZOLE	Natco Pharma USA LLC	da63870d-b426-4e49-9591-5bb51f962e66	2023-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
ITRACONAZOLE	ITRACONAZOLE	Alembic Pharmaceuticals Limited	f9d8b5a7-435f-40e6-8596-5f2376b92c74	2023-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10147-0150	itraconazole	itraconazole	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0150	itraconazole	itraconazole	Patriot Pharmaceuticals,	NDA	Current
10147-0150	itraconazole	itraconazole	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0150	itraconazole	itraconazole	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0150	itraconazole	itraconazole	Patriot Pharmaceuticals, LLC	NDA	Current
50458-295	SPORANOX	itraconazole	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-295	SPORANOX	itraconazole	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-295	SPORANOX	itraconazole	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-295	SPORANOX	itraconazole	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-295	SPORANOX	itraconazole	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80678	SUPPL	2024-12-23
80672	SUPPL	2024-12-20
80031	SUPPL	2024-10-29
80022	SUPPL	2024-10-28
77893	SUPPL	2024-03-21
77872	SUPPL	2024-03-19
77410	SUPPL	2024-02-07
77404	SUPPL	2024-02-06
75906	SUPPL	2023-10-24
75882	SUPPL	2023-10-20
72808	SUPPL	2022-12-07
72798	SUPPL	2022-12-06
57948	SUPPL	2019-03-11
57944	SUPPL	2019-03-11
50032	SUPPL	2017-10-12
49992	SUPPL	2017-10-10
47695	SUPPL	2017-03-24
47660	SUPPL	2017-03-23
25451	SUPPL	2015-04-17
12933	SUPPL	2015-04-17
3010	SUPPL	2014-06-11
35085	SUPPL	2014-06-10
25450	SUPPL	2012-03-27
12932	SUPPL	2012-03-27
12931	SUPPL	2012-03-27
3009	SUPPL	2012-03-27
25449	SUPPL	2011-04-19
12930	SUPPL	2011-04-18
12929	SUPPL	2011-01-11
3008	SUPPL	2011-01-07
3007	SUPPL	2010-08-03
12928	SUPPL	2010-07-31
35084	SUPPL	2009-03-17
35083	SUPPL	2009-03-17
12927	SUPPL	2009-03-17
12926	SUPPL	2009-03-17
3006	SUPPL	2009-03-10
3005	SUPPL	2009-03-10
3004	SUPPL	2009-03-10
3003	SUPPL	2009-03-10
35082	SUPPL	2003-09-30
3002	SUPPL	2003-09-30
35080	SUPPL	2002-09-11
3000	SUPPL	2002-09-11
35081	SUPPL	2002-07-17
3001	SUPPL	2002-07-17
41525	SUPPL	2001-10-26
41524	SUPPL	2001-10-26
35079	SUPPL	2001-04-17
25448	SUPPL	2001-04-17
12925	SUPPL	2001-04-17
2999	SUPPL	2001-04-17