Product NDC: | 0173-0845 |
Proprietary Name: | AVANDARYL |
Non Proprietary Name: | rosiglitazone maleate and glimepiride |
Active Ingredient(s): | 4; 8 mg/1; mg/1 & nbsp; rosiglitazone maleate and glimepiride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0173-0845 |
Labeler Name: | GlaxoSmithKline LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021700 |
Marketing Category: | NDA |
Start Marketing Date: | 20110524 |
Package NDC: | 0173-0845-13 |
Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0845-13) |
NDC Code | 0173-0845-13 |
Proprietary Name | AVANDARYL |
Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0845-13) |
Product NDC | 0173-0845 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | rosiglitazone maleate and glimepiride |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20110524 |
Marketing Category Name | NDA |
Labeler Name | GlaxoSmithKline LLC |
Substance Name | GLIMEPIRIDE; ROSIGLITAZONE MALEATE |
Strength Number | 4; 8 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Peroxisome Proliferator Receptor gamma Agonist [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR gamma [Chemical/Ingredient],Thiazolidinedione [EPC],Thiazolidinediones [Chemical/Ingredient],Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient] |