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Simvastatin - 0378-5405-77 - (Simvastatin)

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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: 0378-5405-77
Package Description: 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5405-77)

NDC Information of Simvastatin

NDC Code 0378-5405-77
Proprietary Name Simvastatin
Package Description 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5405-77)
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]

Complete Information of Simvastatin


General Information