Application 076214

Type: ANDA
Sponsor: APOTEX

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
A076214-001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27
A076214-002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27
A076214-003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076214-001	AB
A076214-002	AB
A076214-003	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	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076214-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2003-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076214-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2003-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076214-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2003-08-27	`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	A076214-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076214-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076214-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076214-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076214-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076214-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076214-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076214-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076214-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076214-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076214-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076214-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076214-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076214-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076214-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076214-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076214-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076214-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076214-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076214-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076214-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076214-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076214-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076214-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076214-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076214-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076214-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076214-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076214-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076214-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076214-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076214-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076214-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076214-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076214-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076214-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076214-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076214-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076214-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076214-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Apotex Corp.	1a56c82e-7ecd-43b0-2899-f89e47adf7db	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076214 application number: ANDA076214 ndc (product): 60505-0222 ndc (product): 60505-0223 ndc (product): 60505-0224
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5ede17b7-3898-4f9f-abec-e15620cef76a	2018-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076214 application number: ANDA076214 ndc (product): 71610-074

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-0222	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0222	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0222	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0222	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0223	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0223	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0223	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0223	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0224	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0224	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0224	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
60505-0224	Sotalol Hydrochloride	Sotalol Hydrochloride	Apotex Corp.	ANDA	Current
71610-074	Sotalol Hydrochloride	Sotalol Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current