| NDC Code | 54868-4164-0 |
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| Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (54868-4164-0) |
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| Product NDC | 54868-4164 |
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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 | 20091007 |
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| Marketing Category Name | NDA |
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| Application Number | NDA020607 |
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| Manufacturer | Physicians Total Care, 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],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [Chemical/Ingredient] |
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