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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 022306

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NDA 022306 describes SOTALOL HYDROCHLORIDE, which is a drug marketed by Altathera Pharms Llc, Apotex, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford Pharms, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs, and is included in seventeen NDAs. It is available from thirteen suppliers. There is one patent protecting this drug. Additional details are available on the SOTALOL HYDROCHLORIDE profile page.

The generic ingredient in SOTALOL HYDROCHLORIDE is sotalol hydrochloride. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 022306
Tradename:SOTALOL HYDROCHLORIDE
Applicant:Altathera Pharms Llc
Ingredient:sotalol hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022306
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories for 022306
Suppliers and Packaging for NDA: 022306
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTALOL HYDROCHLORIDE sotalol hydrochloride SOLUTION;INTRAVENOUS 022306 NDA ALTATHERA Pharmaceuticals, LLC 69724-112 69724-112-10 1 VIAL in 1 CARTON (69724-112-10) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength150MG/10ML (15MG/ML)
Approval Date:Jul 2, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 18, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION.

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Serving leading biopharmaceutical companies globally:

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