Product NDC: | 16729-007 |
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) |
Product NDC: | 16729-007 |
Labeler Name: | Accord Healthcare, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078155 |
Marketing Category: | ANDA |
Start Marketing Date: | 20080226 |
Package NDC: | 16729-007-12 |
Package Description: | 60 TABLET, FILM COATED in 1 BOTTLE (16729-007-12) |
NDC Code | 16729-007-12 |
Proprietary Name | simvastatin |
Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (16729-007-12) |
Product NDC | 16729-007 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | simvastatin |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20080226 |
Marketing Category Name | ANDA |
Labeler Name | Accord Healthcare, Inc. |
Substance Name | SIMVASTATIN |
Strength Number | 80 |
Strength Unit | mg/1 |
Pharmaceutical Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |