| NDC Code | 82111-517-01 |
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| Package Description | 3 BLISTER PACK in 1 CARTON (82111-517-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
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| Product NDC | 82111-517 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Dartisla Odt |
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| Non-Proprietary Name | Glycopyrrolate Orally Disintegrating Tablets |
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| Dosage Form | TABLET, ORALLY DISINTEGRATING |
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| Usage | ORAL |
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| Start Marketing Date | 20231011 |
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| Marketing Category Name | NDA |
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| Application Number | NDA215019 |
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| Manufacturer | Edenbridge Pharmaceuticals LLC. |
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| Substance Name | GLYCOPYRROLATE |
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| Strength | .85 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
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