Application 208901

Type: NDA
Sponsor: MAYNE PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOLSURA	ITRACONAZOLE	CAPSULE;ORAL	65MG	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
N208901-001	TOLSURA	ITRACONAZOLE	65MG	CAPSULE / ORAL		RLD, RS	2018-12-11

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27
N208901-001	10806792	2033-06-21		Drug product	2020-11-24
N208901-001	8921374	2033-06-21		Drug product	2018-12-18
N208901-001	9272046	2033-06-21		Drug product	2018-12-18
N208901-001	9713642	2033-06-21	U-2453		2018-12-18

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208901-001	TOLSURA	65MG	CAPSULE / ORAL	RLD, RS	2018-12-11	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 221 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208901-001	10806792	2033-06-21		Drug product	2020-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208901-001	8921374	2033-06-21		Drug product	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208901-001	9272046	2033-06-21		Drug product	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208901-001	9713642	2033-06-21	U-2453		2018-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208901-001	10806792	2033-06-21		Drug product	2020-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208901-001	8921374	2033-06-21		Drug product	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208901-001	9272046	2033-06-21		Drug product	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208901-001	9713642	2033-06-21	U-2453		2018-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208901-001	10806792	2033-06-21		Drug product	2020-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208901-001	8921374	2033-06-21		Drug product	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208901-001	9272046	2033-06-21		Drug product	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208901-001	9713642	2033-06-21	U-2453		2018-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208901-001	10806792	2033-06-21		Drug product	2020-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208901-001	8921374	2033-06-21		Drug product	2018-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208901-001	9272046	2033-06-21		Drug product	2018-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208901-001	9713642	2033-06-21	U-2453		2018-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208901-001	10806792	2033-06-21		Drug product	2020-11-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208901-001	8921374	2033-06-21		Drug product	2018-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208901-001	9272046	2033-06-21		Drug product	2018-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208901-001	9713642	2033-06-21	U-2453		2018-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208901-001	10806792	2033-06-21		Drug product	2020-11-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208901-001	8921374	2033-06-21		Drug product	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208901-001	9272046	2033-06-21		Drug product	2018-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208901-001	9713642	2033-06-21	U-2453		2018-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208901-001	10806792	2033-06-21		Drug product	2020-11-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208901-001	8921374	2033-06-21		Drug product	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208901-001	9272046	2033-06-21		Drug product	2018-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208901-001	9713642	2033-06-21	U-2453		2018-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208901-001	10463740	2033-06-21	U-2453	Drug product	2019-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208901-001	10806792	2033-06-21		Drug product	2020-11-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208901-001	8921374	2033-06-21		Drug product	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208901-001	9272046	2033-06-21		Drug product	2018-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208901-001	9713642	2033-06-21	U-2453		2018-12-18	`5bbf6a4d5a75…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolsura	ITRACONAZOLE	Mayne Pharma Commercial LLC	306352d1-9d5a-49ad-b72d-893b99546861	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208901 application number: NDA208901 ndc (product): 51862-462

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-462	Tolsura	Itraconazole	Mayne Pharma Inc.	NDA	Current
51862-462	Tolsura	Itraconazole	Mayne Pharma Inc.	NDA	Current
51862-462	Tolsura	Itraconazole	Mayne Pharma Inc.	NDA	Current
51862-462	Tolsura	Itraconazole	Mayne Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80032	SUPPL	2024-10-29
80023	SUPPL	2024-10-28
58804	ORIG	2019-05-21
56838	ORIG	2018-12-20
56716	ORIG	2018-12-12