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FDA Approval

FENOFIBRATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 1, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fenofibrate(54 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

FENOFIBRATE

Product Details

NDC Product Code
33261-966
Application Number
ANDA076509
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 1, 2014
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Code: U202363UOSClass: ACTIBQuantity: 54 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816NClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
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