| NDC Code | 51862-608-30 |
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| Package Description | 30 TABLET in 1 BOTTLE (51862-608-30) |
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| Product NDC | 51862-608 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate |
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| Non-Proprietary Name | Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate |
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| Dosage Form | TABLET |
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| Usage | SUBLINGUAL |
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| Start Marketing Date | 20210528 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA206953 |
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| Manufacturer | Mayne Pharma Inc. |
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| Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE |
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| Strength | 8; 2 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |
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| DEA Schedule | CIII |
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