| 71610-625-53 |
71610-625 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20211210 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
15 mg/1 |
60 CAPSULE in 1 BOTTLE (71610-625-53) |
| 71610-625-60 |
71610-625 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20211210 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
15 mg/1 |
90 CAPSULE in 1 BOTTLE (71610-625-60) |
| 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) |
| 72789-449-30 |
72789-449 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20241106 |
N/A |
NDA |
NDA018163 |
PD-Rx Pharmaceuticals, Inc. |
TEMAZEPAM |
30 mg/1 |
30 CAPSULE in 1 BOTTLE, PLASTIC (72789-449-30) |
| 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) |
| 68084-549-21 |
68084-549 |
HUMAN PRESCRIPTION DRUG |
Temazepam |
Temazepam |
CAPSULE |
ORAL |
20120801 |
N/A |
NDA |
NDA018163 |
American Health Packaging |
TEMAZEPAM |
7.5 mg/1 |
30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11) |
| 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) |