NDC Code | 0378-4541-01 |
Package Description | 100 TABLET in 1 BOTTLE, PLASTIC (0378-4541-01) |
Product NDC | 0378-4541 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate (monohydrate), Dextroamphetamine Sulfate, Amphetamine Sulfate |
Non-Proprietary Name | Dextroamphetamine, Amphetamine, Dextroamphetamine, Amphetamine |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20151110 |
Marketing Category Name | ANDA |
Application Number | ANDA206721 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; 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 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 |