Application 075429

Type: ANDA
Sponsor: TEVA

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
004	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	240MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075429-001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01
A075429-002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01
A075429-003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01
A075429-004	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075429-001	AB
A075429-002	AB
A075429-003	AB
A075429-004	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 5 · 164 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	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075429-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075429-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075429-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075429-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2000-05-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A075429-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075429-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075429-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075429-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075429-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075429-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075429-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075429-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075429-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075429-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075429-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075429-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075429-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075429-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075429-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075429-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075429-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075429-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075429-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075429-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075429-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075429-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075429-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075429-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075429-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075429-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075429-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075429-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075429-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075429-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075429-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075429-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075429-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075429-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075429-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075429-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075429-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075429-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075429-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075429-004	AB	1	`d06236e962d9…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	31404462-7fa0-20d6-e063-6294a90aa58c	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075429 application number: ANDA075429
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Proficient Rx LP	6acf10b5-bbd9-4993-99a9-2cdb8cec96c5	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075429 application number: ANDA075429 ndc (product): 71205-046
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	8e2772cb-7dea-42d1-ba31-d479ba7cb09a	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075429 application number: ANDA075429 ndc (product): 0093-1060 ndc (product): 0093-1062 ndc (product): 0093-1061 ndc (product): 0093-1063

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1060	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1061	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1062	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1063	Sotalol Hydrochloride	Sotalol Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
71205-046	Sotalol Hydrochloride	Sotalol Hydrochloride	Proficient Rx LP	ANDA	Current
71205-046	Sotalol Hydrochloride	Sotalol Hydrochloride	Proficient Rx LP	ANDA	Current
71205-046	Sotalol Hydrochloride	Sotalol Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0860	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0860	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0860	Sotalol Hydrochloride	Sotalol Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30880	ORIG	2004-06-17
18410	ORIG	2004-06-17
42995	ORIG	2001-12-17
30881	ORIG	2000-05-01