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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, Sun Pharm Inds, Mylan, Teva, Watson Labs, Apotex Inc, Impax Pharms, Vintage Pharms, Sandoz, and Epic Pharma Inc, and is included in fifteen NDAs. It is available from twenty-two 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-seven suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

Summary for NDA: 022306

Altathera Pharms Llc
sotalol hydrochloride
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 022306

Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration

Suppliers and Packaging for NDA: 022306

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary 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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