| NDC Code | 52427-698-03 |
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| Package Description | 30 POUCH in 1 CARTON (52427-698-03) > 1 FILM in 1 POUCH (52427-698-11) |
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| Product NDC | 52427-698 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Buprenorphine And Naloxone |
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| Proprietary Name Suffix | Sublingual Film |
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| Non-Proprietary Name | Buprenorphine And Naloxone |
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| Dosage Form | FILM |
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| Usage | BUCCAL; SUBLINGUAL |
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| Start Marketing Date | 20190211 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA205954 |
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| Manufacturer | Almatica 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 | Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA] |
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| DEA Schedule | CIII |
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