| NDC Code | 43386-350-05 |
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| Package Description | 500 TABLET in 1 BOTTLE (43386-350-05) |
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| Product NDC | 43386-350 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
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| Non-Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
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| Dosage Form | TABLET |
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| Usage | ORAL |
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| Start Marketing Date | 20110216 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA091528 |
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| Manufacturer | GAVIS Pharmaceuticals, LLC |
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| Substance Name | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
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| Strength | 1.5; 5 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA] |
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| DEA Schedule | CIII |
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