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 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride generic name: SOTALOL HYDROCHLORIDE
Sotalol Hydrochloride	SOTALOL HYDROCHLORIDE	AvPAK	bcbc1624-283e-732f-e053-2995a90a8f11	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 brand name: SOTALOL HYDROCHLORIDE 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 brand name: SOTALOL HYDROCHLORIDE 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 brand name: SOTALOL HYDROCHLORIDE 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 brand name: SOTALOL HYDROCHLORIDE 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 brand name: Sotalol Hydrochloride 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 brand name: Sotalol Hydrochloride 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 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