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Simvastatin
Simvastatin - 0378-5405-05 - (Simvastatin)
Drug Information of Simvastatin
| Product NDC: | 0378-5405 |
| Proprietary Name: | Simvastatin |
| Non Proprietary Name: | Simvastatin |
| Active Ingredient(s): | 80 mg/1 & nbsp; Simvastatin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Simvastatin
| Product NDC: | 0378-5405 |
| Labeler Name: | Mylan Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090868 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120323 |
Package Information of Simvastatin
| Package NDC: | 0378-5405-05 |
| Package Description: | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5405-05) |
NDC Information of Simvastatin
| NDC Code | 0378-5405-05 |
| Proprietary Name | Simvastatin |
| Package Description | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5405-05) |
| Product NDC | 0378-5405 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Simvastatin |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20120323 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | SIMVASTATIN |
| Strength Number | 80 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |
