| NDC Code | 0054-3194-46 |
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| Package Description | 1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE |
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| Product NDC | 0054-3194 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Diphenoxylate Hydrochloride And Atropine Sulfate |
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| Non-Proprietary Name | Diphenoxylate Hydrochloride And Atropine Sulfate |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 19820503 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA087708 |
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| Manufacturer | Hikma Pharmaceuticals USA Inc. |
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| Substance Name | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
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| Strength | .025; 2.5 |
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| Strength Unit | mg/5mL; mg/5mL |
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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 | CV |
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