| Product NDC: | 0173-0842 |
| Proprietary Name: | AVANDARYL |
| Non Proprietary Name: | rosiglitazone maleate and glimepiride |
| Active Ingredient(s): | 2; 4 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: | 0173-0842 |
| Labeler Name: | GlaxoSmithKline LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021700 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110524 |
| Package NDC: | 0173-0842-13 |
| Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0842-13) |
| NDC Code | 0173-0842-13 |
| Proprietary Name | AVANDARYL |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0842-13) |
| Product NDC | 0173-0842 |
| 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 | 2; 4 |
| 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] |