| NDC Code | 65162-438-03 |
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| Package Description | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-438-03) |
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| Product NDC | 65162-438 |
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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 | 20161201 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA203995 |
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| Manufacturer | Amneal Pharmaceuticals LLC |
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| Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
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| Strength | 75; 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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