| NDC Code | 54868-4965-0 |
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| Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (54868-4965-0) |
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| Product NDC | 54868-4965 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Avandamet |
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| Non-Proprietary Name | Rosiglitazone Maleate And Metformin Hydrochloride |
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| Dosage Form | TABLET, FILM COATED |
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| Usage | ORAL |
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| Start Marketing Date | 20031204 |
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| Marketing Category Name | NDA |
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| Application Number | NDA021410 |
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| Manufacturer | Physicians Total Care, Inc. |
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| Substance Name | ROSIGLITAZONE MALEATE; METFORMIN HYDROCHLORIDE |
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| Strength | 2; 500 |
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| Strength Unit | mg/1; mg/1 |
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| 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] |
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