| 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) |
| 0406-9960-01 |
0406-9960 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20100223 |
N/A |
NDA |
NDA018163 |
SpecGx LLC |
TEMAZEPAM |
7.5 mg/1 |
100 CAPSULE in 1 BOTTLE (0406-9960-01) |
| 71610-626-15 |
71610-626 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20211210 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
30 mg/1 |
15 CAPSULE in 1 BOTTLE (71610-626-15) |
| 71610-626-28 |
71610-626 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20240307 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
30 mg/1 |
28 CAPSULE in 1 BOTTLE (71610-626-28) |
| 71610-626-30 |
71610-626 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20211210 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
30 mg/1 |
30 CAPSULE in 1 BOTTLE (71610-626-30) |
| 71610-626-53 |
71610-626 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20211210 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
30 mg/1 |
60 CAPSULE in 1 BOTTLE (71610-626-53) |
| 71610-626-60 |
71610-626 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20240229 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
30 mg/1 |
90 CAPSULE in 1 BOTTLE (71610-626-60) |