| NDC Code | 0228-3051-11 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE (0228-3051-11) |
|---|
| Product NDC | 0228-3051 |
|---|
| 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 | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20160205 |
|---|
| End Marketing Date | 20180430 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA206340 |
|---|
| Manufacturer | Actavis Pharma, Inc. |
|---|
| Substance Name | DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE |
|---|
| Strength | 5; 5; 5; 5 |
|---|
| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
|---|
| Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
|---|
| DEA Schedule | CII |
|---|