| NDC Code | 54092-471-01 |
|---|
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-471-01) |
|---|
| Product NDC | 54092-471 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Mydayis |
|---|
| Non-Proprietary Name | Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20170620 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA022063 |
|---|
| Manufacturer | Takeda Pharmaceuticals America, Inc. |
|---|
| Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
|---|
| Strength | 6.25; 6.25; 6.25; 6.25 |
|---|
| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE] |
|---|
| DEA Schedule | CII |
|---|