| NDC Code | 0378-4385-91 |
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| Package Description | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4385-91) |
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| Product NDC | 0378-4385 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Naproxen And Esomeprazole Magnesium |
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| Non-Proprietary Name | Naproxen And Esomeprazole Magnesium |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20211122 |
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| End Marketing Date | 20231031 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA204920 |
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| Manufacturer | Mylan Pharmaceuticals Inc. |
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| Substance Name | ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
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| Strength | 20; 375 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
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