Application 075366
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
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 |
|---|---|---|---|---|---|---|---|
| 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.
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 8e2772cb-7dea-42d1-ba31-d479ba7cb09a | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | Sotalol Hydrochloride SOTALOL HYDROCHLORIDE |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0 | 2023-11-06 | Boxed warning, Warnings, Adverse reactions | Sotalol Hydrochloride SOTALOL HYDROCHLORIDE |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Oxford Pharmaceuticals, LLC | c8ac6351-b1e9-4dd2-82f2-5980814fda15 | 2023-11-02 | Boxed warning, Warnings, Adverse reactions | Sotalol Hydrochloride SOTALOL HYDROCHLORIDE |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5e005309-4eca-4536-8743-c6ed9e5b3195 | 2023-08-08 | Boxed warning, Warnings, Adverse reactions | Sotalol Hydrochloride SOTALOL HYDROCHLORIDE |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Proficient Rx LP | 517824b1-11be-40a9-9066-d1a6a32a2938 | 2023-07-01 | Boxed warning, Warnings, Adverse reactions | Sotalol Hydrochloride SOTALOL HYDROCHLORIDE |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 253da1e1-022a-4175-bd7f-e7673cba0767 | 2022-02-22 | Boxed warning, Warnings, Adverse reactions | Sotalol Hydrochloride SOTALOL HYDROCHLORIDE |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5ede17b7-3898-4f9f-abec-e15620cef76a | 2018-06-26 | Boxed warning, Warnings, Adverse reactions | Sotalol Hydrochloride SOTALOL HYDROCHLORIDE |
NDC Listings For This Application#
| 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 |