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FDA Approval

SOTYLIZE

CompanyAzurity Pharmaceuticals, Inc. (DUNS: 117505635)

Effective Date

January 24, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sotalol(5 mg in 1 mL)

Products (1)

SOTYLIZE

NDC Product Code

24338-530

Application Number

NDA205108

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 24, 2024

Ingredients

Code: HEC37C70XXClass: ACTIBQuantity: 5 mg in 1 mL

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

SODIUM CITRATE, UNSPECIFIED FORMInactive

Code: 1Q73Q2JULRClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

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