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. 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-one 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-one 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 |
Medical Subject Heading (MeSH) Categories for 021151
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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