NDC Code | 0480-3684-01 |
Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3684-01) |
Product NDC | 0480-3684 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, 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 | 20231010 |
Marketing Category Name | ANDA |
Application Number | ANDA210876 |
Manufacturer | Teva Pharmaceuticals, Inc. |
Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
Strength | 6.25; 6.25; 6.25; 6.25 |
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 |