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Simvastatin - 65862-052-00 - (Simvastatin)

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Drug Information of Simvastatin

Product NDC: 65862-052
Proprietary Name: Simvastatin
Non Proprietary Name: Simvastatin
Active Ingredient(s): 20    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: 65862-052
Labeler Name: Aurobindo Pharma Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA077691
Marketing Category: ANDA
Start Marketing Date: 20061220

Package Information of Simvastatin

Package NDC: 65862-052-00
Package Description: 100 TABLET, FILM COATED in 1 BOTTLE (65862-052-00)

NDC Information of Simvastatin

NDC Code 65862-052-00
Proprietary Name Simvastatin
Package Description 100 TABLET, FILM COATED in 1 BOTTLE (65862-052-00)
Product NDC 65862-052
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Simvastatin
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20061220
Marketing Category Name ANDA
Labeler Name Aurobindo Pharma Limited
Substance Name SIMVASTATIN
Strength Number 20
Strength Unit mg/1
Pharmaceutical Classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Complete Information of Simvastatin


General Information