| NDC Code | 54868-5376-0 |
|---|
| Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (54868-5376-0) |
|---|
| Product NDC | 54868-5376 |
|---|
| 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 | 20050803 |
|---|
| Marketing Category Name | NDA |
|---|
| Application Number | NDA021410 |
|---|
| Manufacturer | Physicians Total Care, Inc. |
|---|
| Substance Name | ROSIGLITAZONE MALEATE; METFORMIN HYDROCHLORIDE |
|---|
| Strength | 2; 1000 |
|---|
| 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] |
|---|