| NDC Code | 54092-477-01 |
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| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-477-01) |
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| Product NDC | 54092-477 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Mydayis |
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| Non-Proprietary Name | Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, And Amphetamine Sulfate |
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| Dosage Form | CAPSULE, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20170620 |
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| Marketing Category Name | NDA |
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| Application Number | NDA022063 |
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| Manufacturer | Takeda Pharmaceuticals America, Inc. |
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| Substance Name | DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE |
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| Strength | 12.5; 12.5; 12.5; 12.5 |
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| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
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| 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] |
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| DEA Schedule | CII |
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