| NDC Code | 43498-816-01 |
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| Package Description | 50 CARTRIDGE in 1 BOX (43498-816-01) / 1.8 mL in 1 CARTRIDGE |
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| Product NDC | 43498-816 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Articaine Hydrochloride And Epinephrine |
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| Non-Proprietary Name | Articaine Hydrochloride, Epinephrine Bitartrate |
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| Dosage Form | INJECTION, SOLUTION |
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| Usage | SUBMUCOSAL |
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| Start Marketing Date | 20210426 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA022466 |
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| Manufacturer | Burkhart Dental Supply Co., Inc |
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| Substance Name | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
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| Strength | 40; 10 |
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| Strength Unit | mg/mL; ug/mL |
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| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC] |
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