| NDC Code | 43975-278-10 |
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| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-278-10) |
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| Product NDC | 43975-278 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate |
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| Non-Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate 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 | 20200316 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA205401 |
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| Manufacturer | ANI Pharmaceuticals, Inc. |
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| Substance Name | AMPHETAMINE DL-ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
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| Strength | 2.5; 2.5; 2.5; 2.5 |
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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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