| NDC Code | 76385-107-10 |
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| Package Description | 1000 TABLET in 1 BOTTLE (76385-107-10) |
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| Product NDC | 76385-107 |
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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 | TABLET |
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| Usage | ORAL |
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| Start Marketing Date | 20190515 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA210819 |
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| Manufacturer | Bayshore Pharmaceuticals, LLC |
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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/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 | CV |
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