Application 022484

Type: NDA
Sponsor: SEBELA IRELAND LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONMEL	ITRACONAZOLE	TABLET;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022484-001	ONMEL	ITRACONAZOLE	200MG	TABLET / ORAL		RLD	2010-04-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD, RS	2010-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD, RS	2010-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD, RS	2010-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD, RS	2010-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD, RS	2010-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD, RS	2010-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD, RS	2010-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD, RS	2010-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022484-001	ONMEL	200MG	TABLET / ORAL	RLD	2010-04-29	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022484-001	8486456	2028-10-03	U-1054	Drug product	2013-07-29	`e64feba35796…`

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
Itraconazole	ITRACONAZOLE	Amneal Pharmaceuticals LLC	43ded1aa-f825-40fe-aa9a-addd36a07f06	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	Torrent Pharmaceuticals Limited	b1274d78-1096-4ae3-8299-a2e94eaa0ea5	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
Itraconazole	ITRACONAZOLE	Amneal Pharmaceuticals LLC	2ab38a8a-3708-4b97-9f7f-8e554a15348d	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ITRACONAZOLE
SPORANOX	ITRACONAZOLE	Janssen Pharmaceuticals, Inc.	a4d555fa-787c-40fb-bb7d-b0d4f7318fd0	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback 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	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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0259-1420	Onmel	ITRACONAZOLE	Merz Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24320	ORIG	2011-02-17
42535	ORIG	2011-01-11
38757	ORIG	2010-05-07
7455	ORIG	2010-05-05