0406-8951-01 |
0406-8951 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single Entity Amphetamine Product XR |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190422 |
N/A |
ANDA |
ANDA211547 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8951-01) |
0406-8955-01 |
0406-8955 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single Entity Amphetamine Product XR |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190422 |
N/A |
ANDA |
ANDA211547 |
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 (0406-8955-01) |
0406-8953-01 |
0406-8953 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single Entity Amphetamine Product XR |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190422 |
N/A |
ANDA |
ANDA211547 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
3.75 mg/1; 3.75 mg/1; 3.75 mg/1; 3.75 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8953-01) |
0406-8952-01 |
0406-8952 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single Entity Amphetamine Product XR |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190422 |
N/A |
ANDA |
ANDA211547 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
2.5 mg/1; 2.5 mg/1; 2.5 mg/1; 2.5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8952-01) |
0406-8956-01 |
0406-8956 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single Entity Amphetamine Product XR |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190422 |
N/A |
ANDA |
ANDA211547 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
7.5 mg/1; 7.5 mg/1; 7.5 mg/1; 7.5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8956-01) |
0406-8954-01 |
0406-8954 |
HUMAN PRESCRIPTION DRUG |
Mixed Salts of a Single Entity Amphetamine Product XR |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190422 |
N/A |
ANDA |
ANDA211547 |
SpecGx LLC |
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
5 mg/1; 5 mg/1; 5 mg/1; 5 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-8954-01) |