54092-468-01 |
54092-468 |
HUMAN PRESCRIPTION DRUG |
MYDAYIS |
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20170620 |
N/A |
NDA |
NDA022063 |
Takeda Pharmaceuticals America, Inc. |
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 (54092-468-01) |
54092-471-01 |
54092-471 |
HUMAN PRESCRIPTION DRUG |
MYDAYIS |
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20170620 |
N/A |
NDA |
NDA022063 |
Takeda Pharmaceuticals America, Inc. |
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 (54092-471-01) |
54092-474-01 |
54092-474 |
HUMAN PRESCRIPTION DRUG |
MYDAYIS |
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20170620 |
N/A |
NDA |
NDA022063 |
Takeda Pharmaceuticals America, Inc. |
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 (54092-474-01) |
54092-477-01 |
54092-477 |
HUMAN PRESCRIPTION DRUG |
MYDAYIS |
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE |
CAPSULE, EXTENDED RELEASE |
ORAL |
20170620 |
N/A |
NDA |
NDA022063 |
Takeda Pharmaceuticals America, Inc. |
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 (54092-477-01) |