NDC Code | 0378-4386-91 |
Package Description | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4386-91) |
Product NDC | 0378-4386 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Naproxen And Esomeprazole Magnesium |
Non-Proprietary Name | Naproxen And Esomeprazole Magnesium |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20211122 |
End Marketing Date | 20231031 |
Marketing Category Name | ANDA |
Application Number | ANDA204920 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | ESOMEPRAZOLE MAGNESIUM; NAPROXEN |
Strength | 20; 500 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |