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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Boehringer Ingelheim
Express Scripts

Generated: January 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-five 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-nine 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 67457-176-10 1 VIAL in 1 CARTON (67457-176-10) > 10 mL in 1 VIAL
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
Regulatory Exclusivity Expiration:Jul 2, 2016
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Chinese Patent Office

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