SOTYLIZE
These highlights do not include all the information needed to use SOTYLIZE safely and effectively. See full prescribing information for SOTYLIZE. SOTYLIZE (sotalol hydrochloride) oral solution Initial U.S. Approval: 1992
Approved
Approval ID
1f33f900-0777-4a92-a7f7-00cf3d57d95c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
Azurity Pharmaceuticals, Inc.
DUNS: 117505635
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SOTALOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-530
Application NumberNDA205108
Product Classification
M
Marketing Category
C73594
G
Generic Name
SOTALOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2024
FDA Product Classification
INGREDIENTS (6)
SOTALOL HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: HEC37C70XX
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT