NDC Code | 42571-134-60 |
Package Description | 60 TABLET in 1 BOTTLE (42571-134-60) |
Product NDC | 42571-134 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Diclofenac Sodium/misoprostol |
Proprietary Name Suffix | Diclofenac-sodium-misoprostol |
Non-Proprietary Name | Diclofenac Sodium/misoprostol |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20210901 |
Marketing Category Name | ANDA |
Application Number | ANDA204355 |
Manufacturer | Micro Labs Limited |
Substance Name | DICLOFENAC SODIUM; MISOPROSTOL |
Strength | 75; 200 |
Strength Unit | mg/1; ug/1 |
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] |