Sotalol Hydrochloride
These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE/SOTALOL HYDROCHLORIDE AF TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE/SOTALOL HYDROCHLORIDE AF TABLETS SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 SOTALOL HYDROCHLORIDE AF tablets, for oral use Initial U.S. Approval: 1992
Approved
Approval ID
866e5717-3de2-4f19-b7c7-2275caeef78b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2021
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-7143
Application NumberANDA076140
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sotalol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (3)
Sotalol HydrochlorideActive
Quantity: 80 mg in 1 1
Code: HEC37C70XX
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT