0406-9915-03 |
0406-9915 |
HUMAN PRESCRIPTION DRUG |
RESTORIL |
temazepam |
CAPSULE |
ORAL |
19810227 |
N/A |
NDA |
NDA018163 |
SpecGx LLC |
TEMAZEPAM |
7.5 mg/1 |
30 CAPSULE in 1 BOTTLE (0406-9915-03) |
0406-9916-01 |
0406-9916 |
HUMAN PRESCRIPTION DRUG |
RESTORIL |
temazepam |
CAPSULE |
ORAL |
19810227 |
N/A |
NDA |
NDA018163 |
SpecGx LLC |
TEMAZEPAM |
15 mg/1 |
100 CAPSULE in 1 BOTTLE (0406-9916-01) |
0406-9914-03 |
0406-9914 |
HUMAN PRESCRIPTION DRUG |
RESTORIL |
temazepam |
CAPSULE |
ORAL |
19810227 |
N/A |
NDA |
NDA018163 |
SpecGx LLC |
TEMAZEPAM |
22.5 mg/1 |
30 CAPSULE in 1 BOTTLE (0406-9914-03) |
71610-004-30 |
71610-004 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20170814 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
7.5 mg/1 |
30 CAPSULE in 1 BOTTLE (71610-004-30) |
71610-004-53 |
71610-004 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20171122 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
7.5 mg/1 |
60 CAPSULE in 1 BOTTLE (71610-004-53) |
71610-004-60 |
71610-004 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20171122 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
7.5 mg/1 |
90 CAPSULE in 1 BOTTLE (71610-004-60) |