NDC Code | 54868-4965-1 |
Package Description | 20 TABLET, FILM COATED in 1 BOTTLE (54868-4965-1) |
Product NDC | 54868-4965 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Avandamet |
Non-Proprietary Name | Rosiglitazone Maleate And Metformin Hydrochloride |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20031204 |
Marketing Category Name | NDA |
Application Number | NDA021410 |
Manufacturer | Physicians Total Care, Inc. |
Substance Name | ROSIGLITAZONE MALEATE; METFORMIN HYDROCHLORIDE |
Strength | 2; 500 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Biguanide [EPC],Biguanides [Chemical/Ingredient] |