NDC Code | 11534-195-03 |
Package Description | 1000 TABLET in 1 BOTTLE (11534-195-03) |
Product NDC | 11534-195 |
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 | 20180704 |
Marketing Category Name | ANDA |
Application Number | ANDA209799 |
Manufacturer | SUNRISE PHARMACEUTICAL, INC. |
Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE 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 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 |