Sotalol Hydrochloride
- Product NDC
- 0603-5771
- 11-digit product format
- 006035771
- Labeler code
- 0603
- Product ID
- 0603-5771_2398995d-e533-4306-a436-eb87ff0f064f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sotalol Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA075563
- Marketing category
- ANDA
- Marketing start
- 2003-11-07
- Marketing end
- 2019-03-31
- Substance
- SOTALOL HYDROCH
- Active strength
- 160 mg/1
- Pharmacologic classes
- Antiarrhythmic
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0603-5771 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 0603-5771 | 0603-5771-21 | D | Discontinued by firm | 2026-08-10 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0603-5771-21 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0603-5771-21 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0603-5771-21 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0603-5771-21 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0603-5771-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0603-5771-21 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0603-5771-21 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0603-5771-21 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0603-5771-21 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0603-5771-21 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0603-5771-21 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0603-5771-21 | 557ba5c1ecfa… | 9c80585c8c6e… |
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… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-5771-21 | EA - Each | 0603-5771 | 8ade4abf-f699-460e-988c-4d148795c628 | 1 | 2012-07-24 |
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 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 667fc1f2-6ccf-4373-89d8-6a064ee7509e | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| 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 |
| 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 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Bryant Ranch Prepack | 2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0 | 2023-11-06 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Oxford Pharmaceuticals, LLC | c8ac6351-b1e9-4dd2-82f2-5980814fda15 | 2023-11-02 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |
| Sotalol Hydrochloride | SOTALOL HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 253da1e1-022a-4175-bd7f-e7673cba0767 | 2022-02-22 | Boxed warning, Warnings, Adverse reactions | 075563 ANDA075563 |