| NDC Code | 68382-358-78 |
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| Package Description | 3 BLISTER PACK in 1 CARTON (68382-358-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-358-30) |
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| Product NDC | 68382-358 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Topiramate |
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| Non-Proprietary Name | Topiramate |
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| Dosage Form | CAPSULE, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20231113 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA207382 |
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| Manufacturer | Zydus Pharmaceuticals USA Inc. |
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| Substance Name | TOPIRAMATE |
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| Strength | 200 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE] |
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