Application 215602

Type: NDA
Sponsor: AZURITY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLEQSUVY	BACLOFEN	SUSPENSION;ORAL	25MG/5ML	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
N215602-001	FLEQSUVY	BACLOFEN	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N215602-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215602-001	11446246	2037-09-08	U-3433		2022-09-30
N215602-001	11324696	2037-09-29		Drug product	2022-05-16

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`4b0b4de00fa7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL		RLD, RS	2022-02-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215602-001	FLEQSUVY	25MG/5ML	SUSPENSION / ORAL	AB	RLD, RS	2022-02-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215602-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215602-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215602-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215602-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215602-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215602-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215602-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215602-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215602-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215602-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215602-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215602-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215602-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215602-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215602-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215602-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215602-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215602-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215602-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215602-001	AB	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215602-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 55 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	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215602-001	11324696	2037-09-29		Drug product	2022-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215602-001	11446246	2037-09-08	U-3433		2022-09-30	`a67488948f0b…`

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
Baclofen	BACLOFEN	Wilshire Pharmaceuticals, Inc.	4585aafe-0af8-4786-a419-6a7e76671ca2	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215602 application number: NDA215602
FLEQSUVY	BACLOFEN	Azurity Pharmaceuticals, Inc.	9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215602 application number: NDA215602 ndc (product): 52652-6001

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
52652-6001	FLEQSUVY	baclofen	Azurity Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83101	SUPPL	2025-08-15
71774	ORIG	2022-08-11
70120	ORIG	2022-02-08
70115	ORIG	2022-02-08