| NDC Code | 0115-1488-01 |
|---|
| Package Description | 100 CAPSULE in 1 BOTTLE (0115-1488-01) |
|---|
| Product NDC | 0115-1488 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate |
|---|
| Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate |
|---|
| Dosage Form | CAPSULE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20160216 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA076852 |
|---|
| Manufacturer | Amneal Pharmaceuticals of New York LLC |
|---|
| Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
|---|
| Strength | 3.75; 3.75; 3.75; 3.75 |
|---|
| 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 |
|---|