Details for New Drug Application (NDA): 205108
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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 Action | Adrenergic beta-Antagonists |
Physiological Effect | Cardiac 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: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/ML (5MG/ML) | ||||
Approval Date: | Oct 22, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 1, 2034 | Product Flag? | Y | Substance 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 Up | Patent Expiration: | Apr 1, 2034 | Product Flag? | Y | Substance 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 Up | Patent Expiration: | Apr 1, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? |
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