70515-119-06 |
70515-119 |
HUMAN PRESCRIPTION DRUG |
BETAPACE AF |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA021151 |
Covis Pharma US, Inc |
SOTALOL HYDROCHLORIDE |
120 mg/1 |
60 TABLET in 1 BOTTLE (70515-119-06) |
70515-116-06 |
70515-116 |
HUMAN PRESCRIPTION DRUG |
BETAPACE AF |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA021151 |
Covis Pharma US, Inc |
SOTALOL HYDROCHLORIDE |
160 mg/1 |
60 TABLET in 1 BOTTLE (70515-116-06) |
13672-056-00 |
13672-056 |
HUMAN PRESCRIPTION DRUG |
Betapace AF |
sotalol HCl |
TABLET |
ORAL |
20000222 |
N/A |
NDA |
NDA021151 |
Skyepharma Production SAS |
SOTALOL HYDROCHLORIDE |
160 mg/160mg |
60 mg in 1 BOTTLE (13672-056-00) |
13672-054-00 |
13672-054 |
HUMAN PRESCRIPTION DRUG |
Betapace AF |
sotalol HCl |
TABLET |
ORAL |
20000222 |
N/A |
NDA |
NDA021151 |
Skyepharma Production SAS |
SOTALOL HYDROCHLORIDE |
80 mg/80mg |
60 mg in 1 BOTTLE (13672-054-00) |
70515-115-06 |
70515-115 |
HUMAN PRESCRIPTION DRUG |
BETAPACE AF |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA021151 |
Covis Pharma US, Inc |
SOTALOL HYDROCHLORIDE |
80 mg/1 |
60 TABLET in 1 BOTTLE (70515-115-06) |
13672-055-00 |
13672-055 |
HUMAN PRESCRIPTION DRUG |
Betapace AF |
sotalol HCl |
TABLET |
ORAL |
20000222 |
N/A |
NDA |
NDA021151 |
Skyepharma Production SAS |
SOTALOL HYDROCHLORIDE |
120 mg/120mg |
60 mg in 1 BOTTLE (13672-055-00) |