| NDC Code | 64850-503-01 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE (64850-503-01) |
|---|
| Product NDC | 64850-503 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate |
|---|
| Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate |
|---|
| Dosage Form | TABLET |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20221229 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA211352 |
|---|
| Manufacturer | Elite Laboratories, Inc. |
|---|
| Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
|---|
| Strength | 3.125; 3.125; 3.125; 3.125 |
|---|
| 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 |
|---|