13551-002-30 |
13551-002 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
FOR SUSPENSION, EXTENDED RELEASE |
ORAL |
20230501 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
SODIUM OXYBATE |
6 g/1 |
30 PACKET in 1 CARTON (13551-002-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
13551-003-07 |
13551-003 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
FOR SUSPENSION, EXTENDED RELEASE |
ORAL |
20230501 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
SODIUM OXYBATE |
7.5 g/1 |
7 PACKET in 1 CARTON (13551-003-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
13551-003-30 |
13551-003 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
FOR SUSPENSION, EXTENDED RELEASE |
ORAL |
20230501 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
SODIUM OXYBATE |
7.5 g/1 |
30 PACKET in 1 CARTON (13551-003-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
13551-004-07 |
13551-004 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
FOR SUSPENSION, EXTENDED RELEASE |
ORAL |
20230501 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
SODIUM OXYBATE |
9 g/1 |
7 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
13551-002-07 |
13551-002 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
FOR SUSPENSION, EXTENDED RELEASE |
ORAL |
20230501 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
SODIUM OXYBATE |
6 g/1 |
7 PACKET in 1 CARTON (13551-002-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
13551-001-30 |
13551-001 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
FOR SUSPENSION, EXTENDED RELEASE |
ORAL |
20230501 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
SODIUM OXYBATE |
4.5 g/1 |
30 PACKET in 1 CARTON (13551-001-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
13551-001-07 |
13551-001 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
FOR SUSPENSION, EXTENDED RELEASE |
ORAL |
20230501 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
SODIUM OXYBATE |
4.5 g/1 |
7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
13551-004-30 |
13551-004 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
FOR SUSPENSION, EXTENDED RELEASE |
ORAL |
20230501 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
SODIUM OXYBATE |
9 g/1 |
30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
13551-005-01 |
13551-005 |
HUMAN PRESCRIPTION DRUG |
Lumryz |
sodium oxybate |
KIT |
|
20241007 |
N/A |
NDA |
NDA214755 |
Avadel CNS Pharmaceuticals, LLC |
|
|
1 KIT in 1 CARTON (13551-005-01) * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |