13672-053-00 |
13672-053 |
HUMAN PRESCRIPTION DRUG |
Betapace |
sotalol HCl |
TABLET |
ORAL |
19921030 |
N/A |
NDA |
NDA019865 |
Skyepharma Production SAS |
SOTALOL HYDROCHLORIDE |
160 mg/160mg |
100 mg in 1 BOTTLE (13672-053-00) |
83107-008-60 |
83107-008 |
HUMAN PRESCRIPTION DRUG |
BETAPACE AF |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Legacy Pharma USA, Inc. |
SOTALOL HYDROCHLORIDE |
80 mg/1 |
60 TABLET in 1 BOTTLE (83107-008-60) |
83107-006-10 |
83107-006 |
HUMAN PRESCRIPTION DRUG |
BETAPACE |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Legacy Pharma USA, Inc. |
SOTALOL HYDROCHLORIDE |
120 mg/1 |
100 TABLET in 1 BOTTLE (83107-006-10) |
83107-009-60 |
83107-009 |
HUMAN PRESCRIPTION DRUG |
BETAPACE AF |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Legacy Pharma USA, Inc. |
SOTALOL HYDROCHLORIDE |
120 mg/1 |
60 TABLET in 1 BOTTLE (83107-009-60) |
83107-007-10 |
83107-007 |
HUMAN PRESCRIPTION DRUG |
BETAPACE |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Legacy Pharma USA, Inc. |
SOTALOL HYDROCHLORIDE |
160 mg/1 |
100 TABLET in 1 BOTTLE (83107-007-10) |
70515-105-10 |
70515-105 |
HUMAN PRESCRIPTION DRUG |
BETAPACE |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Covis Pharma US, Inc |
SOTALOL HYDROCHLORIDE |
80 mg/1 |
100 TABLET in 1 BOTTLE (70515-105-10) |
13672-051-00 |
13672-051 |
HUMAN PRESCRIPTION DRUG |
Betapace |
sotalol HCl |
TABLET |
ORAL |
19921030 |
N/A |
NDA |
NDA019865 |
Skyepharma Production SAS |
SOTALOL HYDROCHLORIDE |
80 mg/80mg |
100 mg in 1 BOTTLE (13672-051-00) |
83107-010-60 |
83107-010 |
HUMAN PRESCRIPTION DRUG |
BETAPACE AF |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Legacy Pharma USA, Inc. |
SOTALOL HYDROCHLORIDE |
160 mg/1 |
60 TABLET in 1 BOTTLE (83107-010-60) |
70515-106-10 |
70515-106 |
HUMAN PRESCRIPTION DRUG |
BETAPACE |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Covis Pharma US, Inc |
SOTALOL HYDROCHLORIDE |
160 mg/1 |
100 TABLET in 1 BOTTLE (70515-106-10) |
13672-052-00 |
13672-052 |
HUMAN PRESCRIPTION DRUG |
Betapace |
sotalol HCl |
TABLET |
ORAL |
19921030 |
N/A |
NDA |
NDA019865 |
Skyepharma Production SAS |
SOTALOL HYDROCHLORIDE |
120 mg/120mg |
100 mg in 1 BOTTLE (13672-052-00) |
83107-005-10 |
83107-005 |
HUMAN PRESCRIPTION DRUG |
BETAPACE |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Legacy Pharma USA, Inc. |
SOTALOL HYDROCHLORIDE |
80 mg/1 |
100 TABLET in 1 BOTTLE (83107-005-10) |
70515-109-10 |
70515-109 |
HUMAN PRESCRIPTION DRUG |
BETAPACE |
sotalol hydrochloride |
TABLET |
ORAL |
20160901 |
N/A |
NDA |
NDA019865 |
Covis Pharma US, Inc |
SOTALOL HYDROCHLORIDE |
120 mg/1 |
100 TABLET in 1 BOTTLE (70515-109-10) |