Application 214133

Type: NDA
Sponsor: STRONGBRIDGE DUBLIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RECORLEV	LEVOKETOCONAZOLE	TABLET; ORAL	150MG	No	No

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
N214133-001	RECORLEV	LEVOKETOCONAZOLE	150MG	TABLET / ORAL		RLD, RS	2021-12-30

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N214133-001	10098877	2026-01-10	U-3283	2022-01-27
N214133-001	10517868	2026-01-10	U-3283	2022-01-27
N214133-001	10835530	2026-01-10	U-3283	2022-01-27
N214133-001	11478471	2026-01-10	U-3283	2022-10-31
N214133-001	9918984	2028-05-03	U-3283	2022-01-27
N214133-001	11020393	2040-03-02	U-3282	2022-01-27
N214133-001	11278547	2040-03-02	U-3282	2022-03-24
N214133-001	11903940	2040-03-02	U-3821	2024-03-08
N214133-001	12377096	2040-03-02	U-4236	2025-08-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214133-001	NCE*	2026-12-30
N214133-001	ODE-385	2028-12-30

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.

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	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214133-001	RECORLEV	150MG	TABLET / ORAL	RLD, RS	2021-12-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 242 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N214133-001	10098877	2026-01-10	U-3283	2022-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	10517868	2026-01-10	U-3283	2022-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	10835530	2026-01-10	U-3283	2022-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	11478471	2026-01-10	U-3283	2022-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	9918984	2028-05-03	U-3283	2022-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	11020393	2040-03-02	U-3282	2022-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	11278547	2040-03-02	U-3282	2022-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	11903940	2040-03-02	U-3821	2024-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	12377096	2040-03-02	U-4236	2025-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214133-001	10098877	2026-01-10	U-3283	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	10517868	2026-01-10	U-3283	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	10835530	2026-01-10	U-3283	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	11478471	2026-01-10	U-3283	2022-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	9918984	2028-05-03	U-3283	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	11020393	2040-03-02	U-3282	2022-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	11278547	2040-03-02	U-3282	2022-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	11903940	2040-03-02	U-3821	2024-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	12377096	2040-03-02	U-4236	2025-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	10098877	2026-01-10	U-3283	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	10517868	2026-01-10	U-3283	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	10835530	2026-01-10	U-3283	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	11478471	2026-01-10	U-3283	2022-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	9918984	2028-05-03	U-3283	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	11020393	2040-03-02	U-3282	2022-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	11278547	2040-03-02	U-3282	2022-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	11903940	2040-03-02	U-3821	2024-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	12377096	2040-03-02	U-4236	2025-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214133-001	10098877	2026-01-10	U-3283	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214133-001	10517868	2026-01-10	U-3283	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214133-001	10835530	2026-01-10	U-3283	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214133-001	11478471	2026-01-10	U-3283	2022-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214133-001	9918984	2028-05-03	U-3283	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214133-001	11020393	2040-03-02	U-3282	2022-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214133-001	11278547	2040-03-02	U-3282	2022-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214133-001	11903940	2040-03-02	U-3821	2024-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214133-001	10098877	2026-01-10	U-3283	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214133-001	10517868	2026-01-10	U-3283	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214133-001	10835530	2026-01-10	U-3283	2022-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214133-001	11478471	2026-01-10	U-3283	2022-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214133-001	9918984	2026-01-10	U-3283	2022-01-27	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N214133-001	NCE*	2026-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214133-001	ODE-385	2028-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214133-001	NCE*	2026-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214133-001	ODE-385	2028-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	NCE*	2026-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214133-001	ODE-385	2028-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214133-001	NCE*	2026-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214133-001	ODE-385	2028-12-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214133-001	NCE*	2026-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214133-001	ODE-385	2028-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214133-001	NCE*	2026-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214133-001	ODE-385	2028-12-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214133-001	ODE-385	2028-12-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214133-001	ODE-385	2028-12-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214133-001	ODE-385	2028-12-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214133-001	ODE-385	2028-12-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214133-001	ODE-385	2028-12-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214133-001	ODE-385	2028-12-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214133-001	ODE-385	2028-12-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214133-001	ODE-385	2028-12-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214133-001	ODE-385	2028-12-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214133-001	ODE-385	2028-12-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214133-001	ODE-385	2028-12-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214133-001	ODE-385	2028-12-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214133-001	ODE-385	2028-12-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214133-001	ODE-385	2028-12-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214133-001	ODE-385	2028-12-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214133-001	ODE-385	2028-12-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214133-001	ODE-385	2028-12-30	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214133-001	NCE*	2026-12-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214133-001	ODE-385	2028-12-30	`a50c72e98297…`

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
Recorlev	LEVOKETOCONAZOLE	Xeris Pharmaceuticals, Inc.	d4c5fead-bc4a-fb02-e053-2a95a90ae4fc	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214133 application number: NDA214133 ndc (product): 72065-003

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
72065-003	Recorlev	Levoketoconazole	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-003	Recorlev	Levoketoconazole	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-003	Recorlev	Levoketoconazole	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-003	Recorlev	Levoketoconazole	Xeris Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75134	SUPPL	2023-08-18
75131	SUPPL	2023-08-18
75099	SUPPL	2023-08-17
72248	ORIG	2022-10-05
71567	ORIG	2022-07-15
71566	ORIG	2022-07-15
69805	ORIG	2022-01-03