Sotalol Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Altathera Pharmaceuticals, Llc (2015-08-01)
Oldest Current Product
2015-10-15
License(s)
NDA
RxNORM
INJECTION\SOTALOL
FDAOB
INTRAVENOUS\SOLUTION\SOTALOL HYDROCHLORIDE
SPL Active
INTRAVENOUS\INJECTION\SOTALOL HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION\SOTALOL

product(s) by strength(s)

10 ml sotalol hydrochloride 15 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1697240112NDAAltathera Pharmaceuticals, Llc2015-10-15SOTALOL HYDROCHLORIDEINTRAVENOUSINJECTIONNDA022306ff3061ab-d930-4318-a5be-684e38be229e

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA022306SOTALOL HYDROCHLORIDEALTATHERA PHARMACEUTICALS LLC2009-07-02ORPHAN DRUG EXCLUSIVITY [2016-07-02]NDA022306_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022306_001RXSOTALOL HYDROCHLORIDE (150MG/10ML)INTRAVENOUSSOLUTIONTrue2009-07-02SOTALOL HYDROCHLORIDE

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
12afe7385-2441-4e22-b63e-ab8614b275df (view SPL)These highlights do not include all the information needed to use sotalol hydrochloride injection safely and effectively. See full prescribing information for sotalol hydrochloride injection. SOTALOL hydrochloride injection for intravenous useInitial U.S. Approval: 1992prescriptionHuman PrescriptionMylan Institutional Llc2014-09-174674570176
2ff3061ab-d930-4318-a5be-684e38be229e (view SPL)These highlights do not include all the information needed to use sotalol hydrochloride injection safely and effectively. See full prescribing information for sotalol hydrochloride injection. SOTALOL hydrochloride injection for intravenous use Initial U.S. Approval: 1992prescriptionHuman PrescriptionAltathera Pharmaceuticals, Llc2015-08-013697240112

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