Application 076140
- Type
- ANDA
- Sponsor
- APOTEX
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 |
|---|---|---|---|---|---|---|---|
| A076140-001 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | |
| A076140-002 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | |
| A076140-003 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | |
| A076140-004 | SOTALOL HYDROCHLORIDE | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076140-001 | AB |
| A076140-002 | AB |
| A076140-003 | AB |
| A076140-004 | 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 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-001 | SOTALOL HYDROCHLORIDE | 80MG | TABLET / ORAL | AB | 2002-09-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-002 | SOTALOL HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2002-09-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-003 | SOTALOL HYDROCHLORIDE | 160MG | TABLET / ORAL | AB | 2002-09-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-004 | SOTALOL HYDROCHLORIDE | 240MG | TABLET / ORAL | AB | 2002-09-26 | 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 | A076140-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076140-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076140-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076140-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076140-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076140-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076140-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076140-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076140-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076140-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076140-004 | 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 | American Health Packaging | 4614480b-b36e-4dbd-9fc0-d083890d297d | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 68084-654 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | AvPAK | bcbc1624-283e-732f-e053-2995a90a8f11 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 50268-724 50268-725 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Northwind Health Company, LLC | fe82c866-03d4-e07b-e053-6394a90a8b1e | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Major Pharmaceuticals | 866e5717-3de2-4f19-b7c7-2275caeef78b | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 0904-7143 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Cardinal Health 107, LLC | 4f5902e1-9f9f-4c6b-817d-2efbb5e28061 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 55154-8179 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | bc35a3e8-681c-4fe8-96cd-b2a62f024c4b | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 27c73b70-99e8-40e8-8aa9-36d3addd3bb4 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 71335-1125 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 876214ba-59c4-4acc-a8ad-c6bc91837de8 | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 71335-0260 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Golden State Medical Supply, Inc. | 6674d53a-7137-4822-8841-4982f702a1b8 | 2025-08-14 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 60429-748 60429-751 60429-750 60429-749 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Apotex Corp. | 1a56c82e-7ecd-43b0-2899-f89e47adf7db | 2025-07-10 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 60505-0080 60505-0082 60505-0081 60505-0159 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1f2ee505-eb90-885d-e063-6394a90a46a1 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | A-S Medication Solutions | 7cb4879f-31e7-4862-bc0c-d439e592d81c | 2023-12-09 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 50090-1299 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5e005309-4eca-4536-8743-c6ed9e5b3195 | 2023-08-08 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Proficient Rx LP | 517824b1-11be-40a9-9066-d1a6a32a2938 | 2023-07-01 | Boxed warning, Warnings, Adverse reactions | 076140 ANDA076140 63187-804 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-7888 | Sotalol Hydrochloride | Sotalol Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-7143 | Sotalol Hydrochloride | Sotalol Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 50090-1299 | Sotalol Hydrochloride | Sotalol Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1299 | Sotalol Hydrochloride | Sotalol Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1299 | Sotalol Hydrochloride | Sotalol Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1299 | Sotalol Hydrochloride | Sotalol Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1299 | Sotalol Hydrochloride | Sotalol Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-724 | Sotalol Hydrochloride | Sotalol Hydrochloride | AvPAK | ANDA | Current |
| 50268-724 | Sotalol Hydrochloride | Sotalol Hydrochloride | AvPAK | ANDA | Current |
| 50268-725 | Sotalol Hydrochloride | Sotalol Hydrochloride | AvPAK | ANDA | Current |
| 50268-725 | Sotalol Hydrochloride | Sotalol Hydrochloride | AvPAK | ANDA | Current |
| 53217-011 | Sotalol Hydrochloride | Sotalol Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55154-8179 | Sotalol Hydrochloride | Sotalol Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-8179 | Sotalol Hydrochloride | Sotalol Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-8179 | Sotalol Hydrochloride | Sotalol Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8179 | Sotalol Hydrochloride | Sotalol Hydrochloride | Cardinal Health | ANDA | Current |
| 60429-748 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-748 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-748 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-748 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-748 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-749 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-749 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-749 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-749 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-749 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-750 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-750 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-750 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-750 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-750 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-751 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-751 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-751 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-751 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-751 | Sotalol Hydrochloride | Sotalol Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60505-0080 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0080 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0080 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0080 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0081 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0081 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0081 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0081 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0082 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0082 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0082 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0082 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0159 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0159 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0159 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0159 | Sotalol Hydrochloride | Sotalol Hydrochloride | Apotex Corp. | ANDA | Current |
| 63187-804 | Sotalol Hydrochloride | Sotalol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-804 | Sotalol Hydrochloride | Sotalol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-804 | Sotalol Hydrochloride | Sotalol Hydrochloride | Proficient Rx LP | ANDA | Current |
| 68084-654 | Sotalol Hydrochloride | Sotalol Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-654 | Sotalol Hydrochloride | Sotalol Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-654 | Sotalol Hydrochloride | Sotalol Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-654 | Sotalol Hydrochloride | Sotalol Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-654 | Sotalol Hydrochloride | Sotalol Hydrochloride | American Health Packaging | ANDA | Current |
| 70518-3341 | Sotalol Hydrochloride | Sotalol Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0260 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0260 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0260 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1125 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1125 | Sotalol Hydrochloride | Sotalol Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-294 | Sotalol Hydrochloride | Sotalol Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |