Application 021151

Type: NDA
Sponsor: COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETAPACE AF	SOTALOL HYDROCHLORIDE	TABLET;ORAL	80MG	Yes	No
002	BETAPACE AF	SOTALOL HYDROCHLORIDE	TABLET;ORAL	120MG	Yes	No
003	BETAPACE AF	SOTALOL HYDROCHLORIDE	TABLET;ORAL	160MG	Yes	Yes
005	BETAPACE AF	SOTALOL HYDROCHLORIDE	TABLET;ORAL	100MG	No	No
006	BETAPACE AF	SOTALOL HYDROCHLORIDE	TABLET;ORAL	40MG	No	No
007	BETAPACE AF	SOTALOL HYDROCHLORIDE	TABLET;ORAL	60MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021151-001	BETAPACE AF	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RLD	2000-02-22
N021151-002	BETAPACE AF	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	RLD	2000-02-22
N021151-003	BETAPACE AF	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22
N021151-005	BETAPACE AF	SOTALOL HYDROCHLORIDE	100MG	TABLET / ORAL			2003-03-14
N021151-006	BETAPACE AF	SOTALOL HYDROCHLORIDE	40MG	TABLET / ORAL			2003-04-02
N021151-007	BETAPACE AF	SOTALOL HYDROCHLORIDE	60MG	TABLET / ORAL			2003-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021151-001	AB
N021151-002	AB
N021151-003	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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`2680178bc6a6…`

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	N021151-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021151-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021151-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021151-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021151-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021151-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021151-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021151-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021151-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021151-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021151-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021151-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021151-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021151-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021151-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021151-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021151-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021151-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021151-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021151-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021151-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021151-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021151-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021151-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021151-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021151-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021151-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021151-001	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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	9a36d95c-6e93-4e57-befe-b5274f359244	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	c824f6b2-80c5-45a6-a491-4c14c9f5e33d	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	American Health Packaging	4614480b-b36e-4dbd-9fc0-d083890d297d	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol	SOTALOL HYDROCHLORIDE	UNICHEM PHARMACEUTICALS (USA), INC.	56879738-8662-4f5c-8386-761ab2b5e46f	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	282b48b2-f9ff-474a-b01e-68a9ce5edf07	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	51cebe16-4496-4f49-b2db-b7b21c08fa23	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	5962c4ee-c8f7-4e38-ab8c-4848c7644362	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	667fc1f2-6ccf-4373-89d8-6a064ee7509e	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	AvPAK	bcbc1624-283e-732f-e053-2995a90a8f11	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Proficient Rx LP	10b7b81d-9ce7-4025-8559-fdfa41c8b146	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Northwind Health Company, LLC	fe82c866-03d4-e07b-e053-6394a90a8b1e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Major Pharmaceuticals	866e5717-3de2-4f19-b7c7-2275caeef78b	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	A-S Medication Solutions	bbeaba9f-0513-4980-bc29-7f9259a53ecc	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	44d0ce4c-de00-4151-ad7f-48a59040a9b0	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	56dd490f-4d78-447c-a460-f55587e8a764	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	14ee4756-52f2-4bbf-bd79-663839ecb1c5	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	db9b0b36-4c00-45b6-a50a-e08d7c61a17c	2025-11-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	d6c8f659-1c32-4431-bdb2-3211a1c81006	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Cardinal Health 107, LLC	4f5902e1-9f9f-4c6b-817d-2efbb5e28061	2025-11-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	bc35a3e8-681c-4fe8-96cd-b2a62f024c4b	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13672-054	Betapace AF	sotalol HCl	SkyePharma Production SAS	NDA	Current
13672-054	Betapace AF	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-054	Betapace AF	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-055	Betapace AF	sotalol HCl	SkyePharma Production SAS	NDA	Current
13672-055	Betapace AF	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-055	Betapace AF	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-056	Betapace AF	sotalol HCl	SkyePharma Production SAS	NDA	Current
13672-056	Betapace AF	sotalol HCl	Skyepharma Production SAS	NDA	Current
13672-056	Betapace AF	sotalol HCl	Skyepharma Production SAS	NDA	Current
70515-115	BETAPACE AF	sotalol hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-115	BETAPACE AF	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-115	BETAPACE AF	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-116	BETAPACE AF	sotalol hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-116	BETAPACE AF	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-116	BETAPACE AF	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-119	BETAPACE AF	sotalol hydrochloride	Covis Pharma US, Inc	NDA	Current
70515-119	BETAPACE AF	sotalol hydrochloride	Covis Pharma	NDA	Current
70515-119	BETAPACE AF	sotalol hydrochloride	Covis Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
36220	SUPPL	2011-08-24
26912	SUPPL	2011-08-18
14509	SUPPL	2011-02-09
4477	SUPPL	2011-02-09
41987	ORIG	2006-01-11
4476	SUPPL	2003-04-18
26911	SUPPL	2003-03-26
14508	ORIG	2000-02-22
4475	ORIG	2000-02-22