| NDC Code | 0781-2335-01 |
|---|
| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2335-01) |
|---|
| Product NDC | 0781-2335 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate |
|---|
| Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate |
|---|
| Dosage Form | CAPSULE, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20090402 |
|---|
| End Marketing Date | 20270430 |
|---|
| Marketing Category Name | NDA AUTHORIZED GENERIC |
|---|
| Application Number | NDA021303 |
|---|
| Manufacturer | Sandoz Inc |
|---|
| Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
|---|
| Strength | 2.5; 2.5; 2.5; 2.5 |
|---|
| 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 |
|---|