| 0406-0807-01 |
0406-0807 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single-Entity Amphetamine Product |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20231101 |
N/A |
ANDA |
ANDA211546 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
9.375 mg/1; 9.375 mg/1; 9.375 mg/1; 9.375 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0807-01) |
| 0406-0803-01 |
0406-0803 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single-Entity Amphetamine Product |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20231101 |
N/A |
ANDA |
ANDA211546 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
6.25 mg/1; 6.25 mg/1; 6.25 mg/1; 6.25 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0803-01) |
| 0406-0804-01 |
0406-0804 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single-Entity Amphetamine Product |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20231101 |
N/A |
ANDA |
ANDA211546 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
12.5 mg/1; 12.5 mg/1; 12.5 mg/1; 12.5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0804-01) |
| 0406-0805-01 |
0406-0805 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single-Entity Amphetamine Product |
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20231101 |
N/A |
ANDA |
ANDA211546 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
3.125 mg/1; 3.125 mg/1; 3.125 mg/1; 3.125 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0805-01) |