Suppliers and packages for generic ingredient: SOTALOL HYDROCHLORIDE
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SOTALOL HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Altathera Pharms Llc | SOTALOL HYDROCHLORIDE | sotalol hydrochloride | SOLUTION;INTRAVENOUS | 022306 | NDA | ALTATHERA Pharmaceuticals, LLC | 69724-112-10 | 1 VIAL in 1 CARTON (69724-112-10) / 10 mL in 1 VIAL | 2015-10-15 |
| Azurity | SOTYLIZE | sotalol hydrochloride | SOLUTION;ORAL | 205108 | NDA | Azurity Pharmaceuticals, Inc. | 24338-530-25 | 250 mL in 1 BOTTLE (24338-530-25) | 2015-03-01 |
| Azurity | SOTYLIZE | sotalol hydrochloride | SOLUTION;ORAL | 205108 | NDA | Azurity Pharmaceuticals, Inc. | 24338-530-48 | 480 mL in 1 BOTTLE (24338-530-48) | 2015-03-01 |
| Legacy Pharma | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865 | NDA | Skyepharma Production SAS | 13672-051-00 | 100 mg in 1 BOTTLE (13672-051-00) | 1992-10-30 |
| Legacy Pharma | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865 | NDA | Skyepharma Production SAS | 13672-052-00 | 100 mg in 1 BOTTLE (13672-052-00) | 1992-10-30 |
| Legacy Pharma | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865 | NDA | Skyepharma Production SAS | 13672-053-00 | 100 mg in 1 BOTTLE (13672-053-00) | 1992-10-30 |
| Legacy Pharma | BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865 | NDA | Covis Pharma US, Inc | 70515-105-10 | 100 TABLET in 1 BOTTLE (70515-105-10) | 2016-09-01 |
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