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Fenofibrate - 0378-3065-05 - (fenofibrate)

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Drug Information of Fenofibrate

Product NDC: 0378-3065
Proprietary Name: Fenofibrate
Non Proprietary Name: fenofibrate
Active Ingredient(s): 48    mg/1 & nbsp;   fenofibrate
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Fenofibrate

Product NDC: 0378-3065
Labeler Name: Mylan Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA202856
Marketing Category: ANDA
Start Marketing Date: 20130521

Package Information of Fenofibrate

Package NDC: 0378-3065-05
Package Description: 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3065-05)

NDC Information of Fenofibrate

NDC Code 0378-3065-05
Proprietary Name Fenofibrate
Package Description 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3065-05)
Product NDC 0378-3065
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name fenofibrate
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20130521
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc.
Substance Name FENOFIBRATE
Strength Number 48
Strength Unit mg/1
Pharmaceutical Classes Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]

Complete Information of Fenofibrate


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