Details for New Drug Application (NDA): 021151
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The generic ingredient in BETAPACE AF 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 021151
Tradename: | BETAPACE AF |
Applicant: | Legacy Pharma |
Ingredient: | sotalol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021151
Mechanism of Action | Adrenergic beta-Antagonists |
Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for 021151
Suppliers and Packaging for NDA: 021151
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151 | NDA | Skyepharma Production SAS | 13672-054 | 13672-054-00 | 60 mg in 1 BOTTLE (13672-054-00) |
BETAPACE AF | sotalol hydrochloride | TABLET;ORAL | 021151 | NDA | Skyepharma Production SAS | 13672-055 | 13672-055-00 | 60 mg in 1 BOTTLE (13672-055-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
Approval Date: | Feb 22, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
Approval Date: | Feb 22, 2000 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Feb 22, 2000 | TE: | AB | RLD: | Yes |
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