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, Aurobindo Pharma Usa, Beximco Pharms Usa, Epic Pharma Llc, Impax Pharms, Natco Pharma Usa, Oxford Pharms, Rising, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs, and is included in seventeen NDAs. It is available from eighteen suppliers. There are four patents protecting this drug. 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-three suppliers are listed for this compound. 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-three suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 022306
| Tradename: | SOTALOL HYDROCHLORIDE |
| Applicant: | Altathera Pharms Llc |
| Ingredient: | sotalol hydrochloride |
| Patents: | 4 |
Pharmacology for NDA: 022306
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for 022306
Suppliers and Packaging for NDA: 022306
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE | 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 150MG/10ML (15MG/ML) | ||||
| Approval Date: | Jul 2, 2009 | TE: | RLD: | Yes | |||||
| Patent: | 10,512,620 | Patent Expiration: | Aug 14, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR INTRAVENOUS SOTALOL FOR ADMINISTRATION IN A FACILITY THAT CAN PROVIDE CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CARDIAC RESUSCITATION. | ||||||||
| Patent: | 10,512,620 | Patent Expiration: | Aug 14, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INTRAVENOUS SOTALOL DOSING REGIMEN FOR ACHIEVING STEADY STATE EXPOSURE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING | ||||||||
| Patent: | 10,799,138 | Patent Expiration: | Apr 5, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | INTRAVENOUS SOTALOL DOSING REGIMEN FOR USE IN A FACILITY THAT CAN PROVIDE ELECTROCARDIOGRAPHIC MONITORING | ||||||||
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