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Simvastatin - 55289-395-90 - (Simvastatin)

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Drug Information of Simvastatin

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)

Labeler Information of Simvastatin

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 Information of Simvastatin

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 Information of Simvastatin

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]

Complete Information of Simvastatin


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