NDC Code | 0378-5121-01 |
Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5121-01) |
Product NDC | 0378-5121 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Fluvastatin Sodium |
Non-Proprietary Name | Fluvastatin |
Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
Usage | ORAL |
Start Marketing Date | 20150911 |
End Marketing Date | 20190731 |
Marketing Category Name | ANDA |
Application Number | ANDA202458 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | FLUVASTATIN SODIUM |
Strength | 80 |
Strength Unit | mg/1 |
Pharmacy Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |