Product NDC: | 55289-395 |
Proprietary Name: | Simvastatin |
Non Proprietary Name: | Simvastatin |
Active Ingredient(s): | 40 mg/1 & nbsp; Simvastatin |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 55289-395 |
Labeler Name: | PD-Rx Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076052 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110613 |
Package NDC: | 55289-395-90 |
Package Description: | 90 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (55289-395-90) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-395-30) |
NDC Code | 55289-395-90 |
Proprietary Name | Simvastatin |
Package Description | 90 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (55289-395-90) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-395-30) |
Product NDC | 55289-395 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Simvastatin |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20110613 |
Marketing Category Name | ANDA |
Labeler Name | PD-Rx Pharmaceuticals, Inc. |
Substance Name | SIMVASTATIN |
Strength Number | 40 |
Strength Unit | mg/1 |
Pharmaceutical Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |