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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Express Scripts
Fish and Richardson
Federal Trade Commission

Generated: March 17, 2018

DrugPatentWatch Database Preview

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, Apotex Inc, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Sun Pharm Industries, Teva, Upsher-smith Labs, Vintage Pharms, and Watson Labs, and is included in sixteen NDAs. It is available from twenty-four suppliers. 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 022306
Applicant:Altathera Pharms Llc
Ingredient:sotalol hydrochloride
Therapeutic Class:Cardiovascular Agents
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 Mylan Institutional LLC 67457-176 N 67457-176-10
SOTALOL HYDROCHLORIDE sotalol hydrochloride SOLUTION;INTRAVENOUS 022306 NDA ALTATHERA Pharmaceuticals, LLC 69724-112 N 69724-112-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength150MG/10ML (15MG/ML)
Approval Date:Jul 2, 2009TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
US Army
Argus Health

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