| NDC Code | 0406-0803-01 |
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| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0406-0803-01) |
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| Product NDC | 0406-0803 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Mixed Salts Of A Single-entity Amphetamine Product |
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| Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate |
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| Dosage Form | CAPSULE, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20231101 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA211546 |
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| Manufacturer | SpecGx LLC |
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| Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
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| Strength | 6.25; 6.25; 6.25; 6.25 |
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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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