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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 205108


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NDA 205108 describes SOTYLIZE, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. 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-three suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 205108
Tradename:SOTYLIZE
Applicant:Azurity
Ingredient:sotalol hydrochloride
Patents:4
Pharmacology for NDA: 205108
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories for 205108
Suppliers and Packaging for NDA: 205108
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTYLIZE sotalol hydrochloride SOLUTION;ORAL 205108 NDA Azurity Pharmaceuticals, Inc. 24338-530 24338-530-25 250 mL in 1 BOTTLE (24338-530-25)
SOTYLIZE sotalol hydrochloride SOLUTION;ORAL 205108 NDA Azurity Pharmaceuticals, Inc. 24338-530 24338-530-48 480 mL in 1 BOTTLE (24338-530-48)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/ML (5MG/ML)
Approval Date:Oct 22, 2014TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 1, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:INDICATED FOR THE TREATMENT OF VENTRICULAR ARRHYTHMIAS, SUCH AS SUSTAINED VENTRICULAR TACHYCARDIA, THAT IN THE JUDGEMENT OF THE PHYSICIAN ARE LIFE-THREATENING
Patent:⤷  Sign UpPatent Expiration:Apr 1, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:SOTYLIZE IS INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM
Patent:⤷  Sign UpPatent Expiration:Apr 1, 2034Product Flag?YSubstance Flag?Delist Request?

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