Application 075563
- Type
- ANDA
- Sponsor
- OXFORD PHARMS
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075563-001 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | |
| A075563-002 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | |
| A075563-003 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | |
| A075563-004 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075563-001 | AB |
| A075563-002 | AB |
| A075563-003 | AB |
| A075563-004 | 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.
| 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 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2003-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2003-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2003-11-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2003-11-07 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075563-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075563-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075563-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075563-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075563-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075563-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075563-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075563-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075563-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075563-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075563-004 | 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.
| 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 | 075563 ANDA075563 63629-2423 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 667fc1f2-6ccf-4373-89d8-6a064ee7509e | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 63629-2422 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Proficient Rx LP | 10b7b81d-9ce7-4025-8559-fdfa41c8b146 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | A-S Medication Solutions | bbeaba9f-0513-4980-bc29-7f9259a53ecc | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | d6c8f659-1c32-4431-bdb2-3211a1c81006 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e6ea445d-4d7c-4c32-83a7-e7683a56075b | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 72789-137 72789-135 72789-138 72789-136 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Proficient Rx LP | b534c632-3b67-4812-a045-3e582eda6de4 | 2025-02-02 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 0fd4afc7-dbf8-46be-9657-aa83bbb2c026 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 89b33c45-ece8-496f-9c3a-94ebabf73b1b | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 6be8c8f2-3977-4b7f-ad45-38b3254afdab | 2024-02-07 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | f8d0daf3-5eab-44f1-9dec-40e5d9c2bbcf | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 63629-2421 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0 | 2023-11-06 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 71335-1917 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Oxford Pharmaceuticals, LLC | c8ac6351-b1e9-4dd2-82f2-5980814fda15 | 2023-11-02 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 69584-842 69584-844 69584-841 69584-843 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 253da1e1-022a-4175-bd7f-e7673cba0767 | 2022-02-22 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 71610-474 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0603-5769 | Sotalol Hydrochloride | Sotalol Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-5770 | Sotalol Hydrochloride | Sotalol Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-5771 | Sotalol Hydrochloride | Sotalol Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0603-5772 | Sotalol Hydrochloride | Sotalol Hydrochloride | Par Pharmaceutical | ANDA | Current |
| 0615-5552 | Sotalol Hydrochloride | Sotalol Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 43353-616 | Sotalol Hydrochloride | Sotalol Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 63187-426 | Sotalol Hydrochloride | Sotalol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-426 | Sotalol Hydrochloride | Sotalol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-2421 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2421 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2421 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2421 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2422 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2422 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2422 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2422 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2423 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2423 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2423 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2423 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-4719 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68071-2014 | Sotalol Hydrochloride | Sotalol Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68151-2702 | Sotalol Hydrochloride | Sotalol Hydrochloride | Carilion Materials Management | ANDA | Current |
| 69584-841 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-841 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-841 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-842 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-842 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-842 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-843 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-843 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-843 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-844 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-844 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 69584-844 | Sotalol Hydrochloride | Sotalol Hydrochloride | Oxford Pharmaceuticals, LLC | ANDA | Current |
| 71335-1917 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1917 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1917 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-474 | Sotalol Hydrochloride | Sotalol Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-474 | Sotalol Hydrochloride | Sotalol Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72789-135 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-135 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-135 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-135 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-136 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-136 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-136 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-136 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-137 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-137 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-137 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-137 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-138 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-138 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-138 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-138 | Sotalol Hydrochloride | Sotalol Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |