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.
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: | 10,206,895 | 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: | 10,206,895 | 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: | 11,013,703 | Patent Expiration: | Apr 1, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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