| NDC Code | 0591-0397-60 |
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| Package Description | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0591-0397-60) |
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| Product NDC | 0591-0397 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Diclofenac Sodium And Misoprostol |
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| Non-Proprietary Name | Diclofenac Sodium And Misoprostol |
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| Dosage Form | TABLET, DELAYED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20121101 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA201089 |
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| Manufacturer | Actavis Pharma, 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 | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS] |
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