Application 075500

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SORINE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	80MG	No	No
002	SORINE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	160MG	No	No
003	SORINE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	240MG	No	No
004	SORINE	SOTALOL HYDROCHLORIDE	TABLET;ORAL	120MG	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	TE codes	Approval date
A075500-001	SORINE	SOTALOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	2001-04-27
A075500-002	SORINE	SOTALOL HYDROCHLORIDE	160MG	TABLET / ORAL	AB	2001-04-27
A075500-003	SORINE	SOTALOL HYDROCHLORIDE	240MG	TABLET / ORAL	AB	2001-04-27
A075500-004	SORINE	SOTALOL HYDROCHLORIDE	120MG	TABLET / ORAL	AB	2001-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A075500-001	AB
A075500-002	AB
A075500-003	AB
A075500-004	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 5 · 164 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	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075500-001	SORINE	80MG	TABLET / ORAL	AB	2001-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-002	SORINE	160MG	TABLET / ORAL	AB	2001-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-003	SORINE	240MG	TABLET / ORAL	AB	2001-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-004	SORINE	120MG	TABLET / ORAL	AB	2001-04-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A075500-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075500-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075500-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075500-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075500-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075500-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075500-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075500-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075500-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075500-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075500-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075500-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075500-004	AB	1	`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 1 · 5 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	44d0ce4c-de00-4151-ad7f-48a59040a9b0	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	56dd490f-4d78-447c-a460-f55587e8a764	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	14ee4756-52f2-4bbf-bd79-663839ecb1c5	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	Bryant Ranch Prepack	db9b0b36-4c00-45b6-a50a-e08d7c61a17c	2025-11-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500
SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	56326224-fc80-4b89-8ba3-70cb873173b4	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075500 application number: ANDA075500

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-0012	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0012	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0012	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0013	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0013	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0013	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0014	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0014	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0014	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0015	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0015	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0015	Sorine	Sotalol Hydrochloride	Upsher-Smith Laboratories, Inc.	ANDA	Current
55154-5616	Sorine	Sotalol Hydrochloride	Cardinal Health	ANDA	Current
55154-5616	Sorine	Sotalol Hydrochloride	Cardinal Health	ANDA	Current
55154-5616	Sorine	Sotalol Hydrochloride	Cardinal Health	ANDA	Current
55154-5616	Sorine	Sotalol Hydrochloride	Cardinal Health	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30914	ORIG	2001-04-27