Application 075366

Type: ANDA
Sponsor: UPSHER SMITH LABS

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	Approval date
A075366-001	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01
A075366-002	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01
A075366-003	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01
A075366-004	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075366-001	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075366-002	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075366-003	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	2000-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075366-004	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	2000-05-01	`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 2 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	AiPing Pharmaceutical, Inc.	56326224-fc80-4b89-8ba3-70cb873173b4	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: SOTALOL HYDROCHLORIDE 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol hydrochloride generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	Apotex Corp.	1a56c82e-7ecd-43b0-2899-f89e47adf7db	2025-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sotalol Hydrochloride 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 brand name: Sotalol hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 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 brand name: SOTALOL HYDROCHLORIDE 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	A-S Medication Solutions	7cb4879f-31e7-4862-bc0c-d439e592d81c	2023-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sotalol Hydrochloride generic name: SOTALOL HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0170	sotalol hydrochloride	sotalol hydrochloride	Eon Labs, Inc.	ANDA	Current
0185-0171	sotalol hydrochloride	sotalol hydrochloride	Eon Labs, Inc.	ANDA	Current
0185-0174	sotalol hydrochloride	sotalol hydrochloride	Eon Labs, Inc.	ANDA	Current
0185-0177	sotalol hydrochloride	sotalol hydrochloride	Eon Labs, Inc.	ANDA	Current
21695-397	sotalol hydrochloride	sotalol hydrochloride	Rebel Distributors Corp	ANDA	Current
43063-133	sotalol hydrochloride	sotalol hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30862	ORIG	2004-06-18
39481	ORIG	2004-06-17
42985	ORIG	2001-12-18
8634	ORIG	2000-05-01