NDC Code | 54092-389-01 |
Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-389-01) |
Product NDC | 54092-389 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Adderall |
Proprietary Name Suffix | Xr |
Non-Proprietary Name | Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate |
Dosage Form | CAPSULE, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20020522 |
Marketing Category Name | NDA |
Application Number | NDA021303 |
Manufacturer | Takeda Pharmaceuticals America, 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 |