Application 205108

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOTYLIZE	SOTALOL HYDROCHLORIDE	SOLUTION;ORAL	5MG/ML (5MG/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
N205108-001	SOTYLIZE	SOTALOL HYDROCHLORIDE	5MG/ML (5MG/ML)	SOLUTION / ORAL		RLD, RS	2014-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205108-001	10206895	2034-04-01	U-2096	Drug product	2019-03-07
N205108-001	10206895	2034-04-01	U-2494	Drug product	2019-03-07
N205108-001	11013703	2034-04-01		Drug product	2021-05-26
N205108-001	12290495	2034-04-01	U-2096		2025-05-22
N205108-001	12290495	2034-04-01	U-2494		2025-05-22
N205108-001	11850222	2034-11-19	U-2096		2024-01-05
N205108-001	11850222	2034-11-19	U-2494		2024-01-05
N205108-001	9724297	2035-08-31	U-2096	Drug product	2017-09-07

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	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205108-001	SOTYLIZE	5MG/ML (5MG/ML)	SOLUTION / ORAL	RLD, RS	2014-10-22	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 198 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	N205108-001	10206895	2034-04-01	U-2096	Drug product	2019-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205108-001	10206895	2034-04-01	U-2494	Drug product	2019-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205108-001	11013703	2034-04-01		Drug product	2021-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205108-001	12290495	2034-04-01	U-2096		2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205108-001	12290495	2034-04-01	U-2494		2025-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205108-001	11850222	2034-11-19	U-2096		2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205108-001	11850222	2034-11-19	U-2494		2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205108-001	9724297	2035-08-31	U-2096	Drug product	2017-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	10206895	2034-04-01	U-2096	Drug product	2019-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	10206895	2034-04-01	U-2494	Drug product	2019-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	11013703	2034-04-01		Drug product	2021-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	12290495	2034-04-01	U-2096		2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	12290495	2034-04-01	U-2494		2025-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	11850222	2034-11-19	U-2096		2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	11850222	2034-11-19	U-2494		2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205108-001	9724297	2035-08-31	U-2096	Drug product	2017-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205108-001	10206895	2034-04-01	U-2096	Drug product	2019-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205108-001	10206895	2034-04-01	U-2494	Drug product	2019-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205108-001	11013703	2034-04-01		Drug product	2021-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205108-001	12290495	2034-04-01	U-2096		2025-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205108-001	12290495	2034-04-01	U-2494		2025-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205108-001	11850222	2034-11-19	U-2096		2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205108-001	11850222	2034-11-19	U-2494		2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205108-001	9724297	2035-08-31	U-2096	Drug product	2017-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205108-001	10206895	2034-04-01	U-2096	Drug product	2019-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205108-001	10206895	2034-04-01	U-2494	Drug product	2019-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205108-001	11013703	2034-04-01		Drug product	2021-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205108-001	11850222	2034-11-19	U-2096		2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205108-001	11850222	2034-11-19	U-2494		2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205108-001	9724297	2035-08-31	U-2096	Drug product	2017-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205108-001	10206895	2034-04-01	U-2096	Drug product	2019-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205108-001	10206895	2034-04-01	U-2494	Drug product	2019-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205108-001	11013703	2034-04-01		Drug product	2021-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205108-001	11850222	2034-11-19	U-2096		2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205108-001	11850222	2034-11-19	U-2494		2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205108-001	9724297	2035-08-31	U-2096	Drug product	2017-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205108-001	10206895	2034-04-01	U-2096	Drug product	2019-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205108-001	10206895	2034-04-01	U-2494	Drug product	2019-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205108-001	11013703	2034-04-01		Drug product	2021-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205108-001	11850222	2034-11-19	U-2096		2024-01-05	`03ed91905a0d…`

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
SOTYLIZE	SOTALOL HYDROCHLORIDE	Azurity Pharmaceuticals, Inc.	1f33f900-0777-4a92-a7f7-00cf3d57d95c	2024-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205108 application number: NDA205108 ndc (product): 24338-530

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
24338-530	SOTYLIZE	SOTALOL HYDROCHLORIDE	Arbor Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77225	SUPPL	2024-01-16
77219	SUPPL	2024-01-16
32631	ORIG	2014-12-18
22974	ORIG	2014-12-18
40444	ORIG	2014-10-24