| NDC Code | 42858-055-01 |
|---|
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-055-01) |
|---|
| Product NDC | 42858-055 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Extended-release |
|---|
| Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20190822 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA210651 |
|---|
| Manufacturer | Rhodes Pharmaceuticals LLC |
|---|
| Substance Name | DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
|---|
| Strength | 1.25; 1.25; 1.25; 1.25 |
|---|
| 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 |
|---|