| NDC Code | 68084-978-32 |
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| Package Description | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-978-32) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68084-978-33) |
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| Product NDC | 68084-978 |
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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 | 20150331 |
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| End Marketing Date | 20171031 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA201089 |
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| Manufacturer | American Health Packaging |
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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 | 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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