NDC Code | 68382-956-01 |
Package Description | 100 TABLET in 1 BOTTLE (68382-956-01) |
Product NDC | 68382-956 |
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 | 20171031 |
Marketing Category Name | ANDA |
Application Number | ANDA207340 |
Manufacturer | Zydus Pharmaceuticals (USA) Inc. |
Substance Name | AMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE |
Strength | 7.5; 7.5; 7.5; 7.5 |
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 |