NDC Code | 63126-341-90 |
Package Description | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63126-341-90) |
Product NDC | 63126-341 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Diclofenac Sodium And Misoprostol Delayed-release |
Non-Proprietary Name | Diclofenac Sodium And Misoprostol |
Dosage Form | TABLET, DELAYED RELEASE |
Usage | ORAL |
Start Marketing Date | 20200630 |
Marketing Category Name | ANDA |
Application Number | ANDA205143 |
Manufacturer | Yung Shin Pharmaceutical Industrual Co., Ltd. |
Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
Strength | 50; 200 |
Strength Unit | mg/1; ug/1 |
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] |