| 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) |
| 0406-9959-03 |
0406-9959 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20100223 |
N/A |
NDA |
NDA018163 |
SpecGx LLC |
TEMAZEPAM |
22.5 mg/1 |
30 CAPSULE in 1 BOTTLE (0406-9959-03) |
| 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) |
| 0406-9915-01 |
0406-9915 |
HUMAN PRESCRIPTION DRUG |
RESTORIL |
temazepam |
CAPSULE |
ORAL |
19810227 |
N/A |
NDA |
NDA018163 |
SpecGx LLC |
TEMAZEPAM |
7.5 mg/1 |
100 CAPSULE in 1 BOTTLE (0406-9915-01) |
| 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) |
| 71610-625-10 |
71610-625 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20240614 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
15 mg/1 |
10 CAPSULE in 1 BOTTLE (71610-625-10) |
| 71610-625-15 |
71610-625 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20211210 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
15 mg/1 |
15 CAPSULE in 1 BOTTLE (71610-625-15) |
| 71610-625-20 |
71610-625 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20240614 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
15 mg/1 |
20 CAPSULE in 1 BOTTLE (71610-625-20) |
| 71610-625-28 |
71610-625 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20240614 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
15 mg/1 |
28 CAPSULE in 1 BOTTLE (71610-625-28) |
| 71610-625-30 |
71610-625 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20211210 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
15 mg/1 |
30 CAPSULE in 1 BOTTLE (71610-625-30) |
| 71610-625-45 |
71610-625 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20211210 |
N/A |
NDA |
NDA018163 |
Aphena Pharma Solutions - Tennessee, LLC |
TEMAZEPAM |
15 mg/1 |
45 CAPSULE in 1 BOTTLE (71610-625-45) |
| 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) |
| 0406-9960-01 |
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) |
| 0406-9917-01 |
0406-9917 |
HUMAN PRESCRIPTION DRUG |
RESTORIL |
temazepam |
CAPSULE |
ORAL |
19810227 |
N/A |
NDA |
NDA018163 |
SpecGx LLC |
TEMAZEPAM |
30 mg/1 |
100 CAPSULE in 1 BOTTLE (0406-9917-01) |
| 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) |
| 0406-9962-01 |
0406-9962 |
HUMAN PRESCRIPTION DRUG |
TEMAZEPAM |
temazepam |
CAPSULE |
ORAL |
20100223 |
N/A |
NDA |
NDA018163 |
SpecGx LLC |
TEMAZEPAM |
30 mg/1 |
100 CAPSULE in 1 BOTTLE (0406-9962-01) |
| 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) |