| NDC Code | 42367-110-09 |
|---|
| Package Description | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (42367-110-09) |
|---|
| Product NDC | 42367-110 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Diclofenac Sodium And Misoprostol |
|---|
| Proprietary Name Suffix | Delayed-release |
|---|
| Non-Proprietary Name | Diclofenac Sodium And Misoprostol |
|---|
| Dosage Form | TABLET, DELAYED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20140715 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA200540 |
|---|
| Manufacturer | Eagle Pharmaceuticals, Inc. |
|---|
| Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
|---|
| Strength | 50; .2 |
|---|
| Strength Unit | mg/1; mg/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] |
|---|