Details for New Drug Application (NDA): 021151
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NDA 021151 describes BETAPACE AF, which is a drug marketed by Legacy Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the BETAPACE AF profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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