| NDC Code | 54766-200-04 |
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| Package Description | 4 TABLET in 1 BLISTER PACK (54766-200-04) |
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| Product NDC | 54766-200 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Motofen |
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| Non-Proprietary Name | Difenoxin And Atropine Sulfate |
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| Dosage Form | TABLET |
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| Usage | ORAL |
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| Start Marketing Date | 20170411 |
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| Marketing Category Name | NDA |
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| Application Number | NDA017744 |
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| Manufacturer | Sebela Pharmaceuticals Inc. |
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| Substance Name | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE |
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| Strength | .025; 1 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
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| DEA Schedule | CIV |
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