Application 022306

Type: NDA
Sponsor: ALTATHERA PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	SOLUTION;INTRAVENOUS	150MG/10ML (15MG/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
N022306-001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2009-07-02

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
N022306-001	12403109	2028-08-14	U-2769	2025-09-12
N022306-001	10512620	2038-08-14	U-2769	2020-03-26
N022306-001	10512620	2038-08-14	U-3547	2020-03-26
N022306-001	11696902	2038-08-14	U-2769	2023-07-31
N022306-001	12390431	2038-08-14	U-2769	2025-09-04
N022306-001	10799138	2039-04-05	U-3125	2021-06-11
N022306-001	10799138	2039-04-05	U-3549	2021-06-11
N022306-001	12569183	2039-04-05	U-4456	2026-04-09
N022306-001	11583216	2039-08-21	U-3549	2023-03-27

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	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022306-001	SOTALOL HYDROCHLORIDE	150MG/10ML (15MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2009-07-02	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 166 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022306-001	12403109	2028-08-14	U-2769	2025-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022306-001	10512620	2038-08-14	U-2769	2020-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022306-001	10512620	2038-08-14	U-3547	2020-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022306-001	11696902	2038-08-14	U-2769	2023-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022306-001	12390431	2038-08-14	U-2769	2025-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022306-001	10799138	2039-04-05	U-3549	2021-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022306-001	10799138	2039-04-05	U-3125	2021-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022306-001	11583216	2039-08-21	U-3549	2023-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	12403109	2028-08-14	U-2769	2025-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	10512620	2038-08-14	U-2769	2020-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	10512620	2038-08-14	U-3547	2020-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	11696902	2038-08-14	U-2769	2023-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	12390431	2038-08-14	U-2769	2025-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	10799138	2039-04-05	U-3549	2021-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	10799138	2039-04-05	U-3125	2021-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022306-001	11583216	2039-08-21	U-3549	2023-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022306-001	10512620	2038-08-14	U-2769	2020-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022306-001	10512620	2038-08-14	U-3547	2020-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022306-001	11696902	2038-08-14	U-2769	2023-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022306-001	10799138	2039-04-05	U-3549	2021-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022306-001	10799138	2039-04-05	U-3125	2021-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022306-001	11583216	2039-08-21	U-3549	2023-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022306-001	10512620	2038-08-14	U-2769	2020-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022306-001	10512620	2038-08-14	U-3547	2020-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022306-001	11696902	2038-08-14	U-2769	2023-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022306-001	10799138	2039-04-05	U-3549	2021-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022306-001	10799138	2039-04-05	U-3125	2021-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022306-001	11583216	2039-08-21	U-3549	2023-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022306-001	10512620	2038-08-14	U-2769	2020-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022306-001	10512620	2038-08-14	U-3547	2020-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022306-001	11696902	2038-08-14	U-2769	2023-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022306-001	10799138	2039-04-05	U-3549	2021-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022306-001	10799138	2039-04-05	U-3125	2021-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022306-001	11583216	2039-08-21	U-3549	2023-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022306-001	10512620	2038-08-14	U-2769	2020-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022306-001	10512620	2038-08-14	U-3547	2020-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022306-001	11696902	2038-08-14	U-2769	2023-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022306-001	10799138	2039-04-05	U-3549	2021-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022306-001	10799138	2039-04-05	U-3125	2021-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022306-001	11583216	2039-08-21	U-3549	2023-03-27	`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
Sotalol hydrochloride	SOTALOL HYDROCHLORIDE	ALTATHERA Pharmaceuticals, LLC	ff3061ab-d930-4318-a5be-684e38be229e	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022306 application number: NDA022306 ndc (product): 69724-112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69724-112	Sotalol hydrochloride	Sotalol hydrochloride	ALTATHERA Pharmaceuticals, LLC	NDA	Current
69724-112	Sotalol hydrochloride	Sotalol hydrochloride	ALTATHERA Pharmaceuticals, LLC	NDA	Current
69724-112	Sotalol hydrochloride	Sotalol hydrochloride	ALTATHERA Pharmaceuticals, LLC	NDA	Current
69724-112	Sotalol hydrochloride	Sotalol hydrochloride	ALTATHERA Pharmaceuticals, LLC	NDA	Current
69724-112	Sotalol hydrochloride	Sotalol hydrochloride	ALTATHERA Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82936	SUPPL	2025-07-25
82919	SUPPL	2025-07-25
75545	SUPPL	2023-09-22
75536	SUPPL	2023-09-22
62099	SUPPL	2020-03-13
62086	SUPPL	2020-03-09
44732	ORIG	2010-03-30
42483	ORIG	2010-03-30
38538	ORIG	2009-07-09
7207	ORIG	2009-07-09