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Generated: April 28, 2017

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Details for New Drug Application (NDA): 205108

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NDA 205108 describes SOTYLIZE, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the SOTYLIZE profile page.

The generic ingredient in SOTYLIZE 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 NDA: 205108

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205108

Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration

Suppliers and Packaging for NDA: 205108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sotalol hydrochloride
SOLUTION;ORAL 205108 NDA Arbor Pharmaceuticals, Inc. 24338-530 24338-530-25 250 mL in 1 BOTTLE (24338-530-25)
sotalol hydrochloride
SOLUTION;ORAL 205108 NDA Arbor Pharmaceuticals, Inc. 24338-530 24338-530-48 480 mL in 1 BOTTLE (24338-530-48)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/ML (5MG/ML)
Approval Date:Oct 22, 2014TE:RLD:Yes

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