| NDC Code | 52054-513-09 |
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| Package Description | 1 BOTTLE in 1 CARTON (52054-513-09) > 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE |
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| Product NDC | 52054-513 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Dexedrine |
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| Proprietary Name Suffix | Spansule |
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| Non-Proprietary Name | Dextroamphetamine Sulfate |
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| Dosage Form | CAPSULE, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 19760802 |
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| End Marketing Date | 20191201 |
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| Marketing Category Name | NDA |
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| Application Number | NDA017078 |
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| Manufacturer | Amedra Pharmaceuticals LLC |
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| Substance Name | DEXTROAMPHETAMINE SULFATE |
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| Strength | 10 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
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| DEA Schedule | CII |
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