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 43.

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 · 258 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
2026-09-14 22:38:34	2026-08	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021151-001	BETAPACE AF	80MG	TABLET / ORAL	AB	RLD	2000-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021151-002	BETAPACE AF	120MG	TABLET / ORAL	AB	RLD	2000-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021151-003	BETAPACE AF	160MG	TABLET / ORAL	AB	RLD, RS	2000-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021151-005	BETAPACE AF	100MG	TABLET / ORAL			2003-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021151-006	BETAPACE AF	40MG	TABLET / ORAL			2003-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021151-007	BETAPACE AF	60MG	TABLET / ORAL			2003-04-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021151-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021151-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021151-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021151-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021151-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021151-003	AB	1	`caaa826d4ba7…`
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…`

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 2 of 3 · 46 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	bc35a3e8-681c-4fe8-96cd-b2a62f024c4b	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	56326224-fc80-4b89-8ba3-70cb873173b4	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e6ea445d-4d7c-4c32-83a7-e7683a56075b	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	27c73b70-99e8-40e8-8aa9-36d3addd3bb4	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	876214ba-59c4-4acc-a8ad-c6bc91837de8	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	6674d53a-7137-4822-8841-4982f702a1b8	2025-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol hydrochloride	SOTALOL HYDROCHLORIDE	ALTATHERA Pharmaceuticals, LLC	ff3061ab-d930-4318-a5be-684e38be229e	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol hydrochloride	SOTALOL HYDROCHLORIDE	Epic Pharma, LLC	c0a34c56-9641-4592-9754-bcc233ec86b6	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	31404462-7fa0-20d6-e063-6294a90aa58c	2025-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Proficient Rx LP	b534c632-3b67-4812-a045-3e582eda6de4	2025-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
BETAPACE	SOTALOL HYDROCHLORIDE	Legacy Pharma USA, Inc.	a6a7702f-36c9-45db-b640-453dc324baee	2024-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BETAPACE AF generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Aurobindo Pharma Limited	6f3145d7-f3c9-4456-a77d-d04c54f24668	2024-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Proficient Rx LP	6acf10b5-bbd9-4993-99a9-2cdb8cec96c5	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1f2ee505-eb90-885d-e063-6394a90a46a1	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	0fd4afc7-dbf8-46be-9657-aa83bbb2c026	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	89b33c45-ece8-496f-9c3a-94ebabf73b1b	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	6be8c8f2-3977-4b7f-ad45-38b3254afdab	2024-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
SOTYLIZE	SOTALOL HYDROCHLORIDE	Azurity Pharmaceuticals, Inc.	1f33f900-0777-4a92-a7f7-00cf3d57d95c	2024-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	f8d0daf3-5eab-44f1-9dec-40e5d9c2bbcf	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	8e2772cb-7dea-42d1-ba31-d479ba7cb09a	2023-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: SOTALOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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