NDC Code | 0378-1071-01 |
Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-1071-01) |
Product NDC | 0378-1071 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Dextroamphetamine Sulfate |
Non-Proprietary Name | Dextroamphetamine |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20160720 |
End Marketing Date | 20190731 |
Marketing Category Name | ANDA |
Application Number | ANDA206735 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | DEXTROAMPHETAMINE SULFATE |
Strength | 10 |
Strength Unit | mg/1 |
Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
DEA Schedule | CII |