| NDC Code | 0078-0434-05 |
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| Package Description | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0434-05) |
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| Product NDC | 0078-0434 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Focalin |
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| Proprietary Name Suffix | Xr |
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| Non-Proprietary Name | Dexmethylphenidate Hydrochloride |
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| Dosage Form | CAPSULE, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20050531 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021802 |
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| Manufacturer | Novartis Pharmaceuticals Corporation |
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| Substance Name | DEXMETHYLPHENIDATE HYDROCHLORIDE |
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| Strength | 40 |
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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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