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Simvastatin - 55111-197-78 - (Simvastatin)

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Drug Information of Simvastatin

Product NDC: 55111-197
Proprietary Name: Simvastatin
Non Proprietary Name: Simvastatin
Active Ingredient(s): 5    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: 55111-197
Labeler Name: Dr. Reddy's Laboratories Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078425
Marketing Category: ANDA
Start Marketing Date: 20070816

Package Information of Simvastatin

Package NDC: 55111-197-78
Package Description: 10 DOSE PACK in 1 BOX (55111-197-78) > 10 TABLET, FILM COATED in 1 DOSE PACK

NDC Information of Simvastatin

NDC Code 55111-197-78
Proprietary Name Simvastatin
Package Description 10 DOSE PACK in 1 BOX (55111-197-78) > 10 TABLET, FILM COATED in 1 DOSE PACK
Product NDC 55111-197
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Simvastatin
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20070816
Marketing Category Name ANDA
Labeler Name Dr. Reddy's Laboratories Limited
Substance Name SIMVASTATIN
Strength Number 5
Strength Unit mg/1
Pharmaceutical Classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Complete Information of Simvastatin


General Information