Application 207428

Type: ANDA
Sponsor: BEXIMCO PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	80MG	No	No
002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	120MG	No	No
003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	160MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207428-001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21
A207428-002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21
A207428-003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207428-001	AB
A207428-002	AB
A207428-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2016-10-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2016-10-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207428-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2016-10-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207428-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207428-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207428-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207428-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207428-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207428-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207428-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207428-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207428-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207428-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207428-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207428-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207428-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207428-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207428-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207428-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207428-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207428-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207428-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207428-001	AB	1	`8072bd15b7f6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	c824f6b2-80c5-45a6-a491-4c14c9f5e33d	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428 ndc (product): 71335-1189
Sotalol	SOTALOL HYDROCHLORIDE	UNICHEM PHARMACEUTICALS (USA), INC.	56879738-8662-4f5c-8386-761ab2b5e46f	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428 ndc (product): 76385-114 ndc (product): 76385-116 ndc (product): 76385-115
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	282b48b2-f9ff-474a-b01e-68a9ce5edf07	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	51cebe16-4496-4f49-b2db-b7b21c08fa23	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	5962c4ee-c8f7-4e38-ab8c-4848c7644362	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207428 application number: ANDA207428

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-661	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-661	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-661	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-662	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-662	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-662	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-663	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-663	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-663	Sotalol	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-715	Sotalol Hydrochloride	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-716	Sotalol Hydrochloride	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-717	Sotalol Hydrochloride	Sotalol Hydrochloride	Marlex Pharmaceuticals Inc	ANDA	Current
71335-1189	Sotalol	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1189	Sotalol	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-385	Sotalol	Sotalol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76385-114	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-114	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-114	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-115	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-115	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-115	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-116	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-116	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-116	Sotalol	Sotalol Hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current