| NDC Code | 70518-4638-0 |
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| Package Description | 50 POUCH in 1 BOX (70518-4638-0) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-4638-1) |
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| Product NDC | 70518-4638 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Lamotrigine |
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| Non-Proprietary Name | Lamotrigine Extended-release |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20260427 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA213949 |
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| Manufacturer | REMEDYREPACK INC. |
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| Substance Name | LAMOTRIGINE |
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| Strength | 200 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA] |
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