Betapace AF is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Skyepharma Production Sas. The primary component is Sotalol Hydrochloride.
Product ID | 13672-055_754a6348-953f-4e8e-e053-2991aa0adde2 |
NDC | 13672-055 |
Product Type | Human Prescription Drug |
Proprietary Name | Betapace AF |
Generic Name | Sotalol Hcl |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2000-02-22 |
Marketing Category | NDA / NDA |
Application Number | NDA021151 |
Labeler Name | SkyePharma Production SAS |
Substance Name | SOTALOL HYDROCHLORIDE |
Active Ingredient Strength | 120 mg/120mg |
Pharm Classes | Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2019-12-31 |
Marketing Start Date | 2000-02-22 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021151 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2000-02-22 |
Ingredient | Strength |
---|---|
SOTALOL HYDROCHLORIDE | 120 mg/120mg |
NDC | Brand Name | Generic Name |
---|---|---|
13672-054 | Betapace AF | sotalol HCl |
13672-055 | Betapace AF | sotalol HCl |
13672-056 | Betapace AF | sotalol HCl |
70515-115 | BETAPACE AF | sotalol hydrochloride |
70515-116 | BETAPACE AF | sotalol hydrochloride |
70515-119 | BETAPACE AF | sotalol hydrochloride |
13672-051 | Betapace | sotalol HCl |
13672-052 | Betapace | sotalol HCl |
13672-053 | Betapace | sotalol HCl |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BETAPACE AF 75817196 2711659 Live/Registered |
COVIS PHARMA B.V. 1999-10-06 |