| NDC Code | 55289-406-15 |
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| Package Description | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-406-15) |
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| Product NDC | 55289-406 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Arthrotec |
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| Non-Proprietary Name | Diclofenac Sodium And Misoprostol |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 19971224 |
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| Marketing Category Name | NDA |
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| Application Number | NDA020607 |
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| Manufacturer | PD-Rx Pharmaceuticals, Inc. |
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| Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
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| Strength | 50; 200 |
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| Strength Unit | mg/1; ug/1 |
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| Pharmacy Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS] |
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