Sotalol Oral Solution

Brand(s)
Sotylize
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Arbor Pharmaceuticals, Inc. (2014-10-31)
Oldest Current Product
2015-03-01
License(s)
NDA
RxNORM
ORAL SOLUTION\SOTALOL
FDAOB
ORAL\SOLUTION\SOTALOL HYDROCHLORIDE
SPL Active
ORAL\SOLUTION\SOTALOL HYDROCHLORIDE
SPL Moiety
ORAL\SOLUTION\SOTALOL

product(s) by strength(s)

sotalol hydrochloride 5 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1243380530SotylizeNDAArbor Pharmaceuticals, Inc.2015-03-01SOTALOL HYDROCHLORIDEORALSOLUTIONNDA2051081f33f900-0777-4a92-a7f7-00cf3d57d95c

application(s)

#idtitleapplicantapprovedapproved drug
1NDA205108SOTYLIZEARBOR PHARMACEUTICALS LLC2014-10-22NDA205108_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205108_001RXSOTALOL HYDROCHLORIDE (5MG/ML)ORALSOLUTIONTrue2014-10-22SOTYLIZE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
11f33f900-0777-4a92-a7f7-00cf3d57d95c (view SPL)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 solutionInitial U.S. Approval: 1992prescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.2014-10-313243380530

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII