Details for New Drug Application (NDA): 019865
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NDA 019865 describes BETAPACE, which is a drug marketed by Legacy Pharma and is included in two NDAs. It is available from one supplier. Additional details are available on the BETAPACE profile page.
The generic ingredient in BETAPACE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
The generic ingredient in BETAPACE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 019865
| Tradename: | BETAPACE |
| Applicant: | Legacy Pharma |
| Ingredient: | sotalol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 019865
| Mechanism of Action | Adrenergic beta-Antagonists |
| Physiological Effect | Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for 019865
Suppliers and Packaging for NDA: 019865
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865 | NDA | Legacy Pharma USA, Inc. | 83107-005 | 83107-005-10 | 100 TABLET in 1 BOTTLE (83107-005-10) |
| BETAPACE | sotalol hydrochloride | TABLET;ORAL | 019865 | NDA | Legacy Pharma USA, Inc. | 83107-006 | 83107-006-10 | 100 TABLET in 1 BOTTLE (83107-006-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Oct 30, 1992 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
| Approval Date: | Oct 30, 1992 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 240MG | ||||
| Approval Date: | Oct 30, 1992 | TE: | AB | RLD: | Yes | ||||
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