Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076520
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription AB No No
FENOFIBRATE FENOFIBRATE 107MG TABLET;ORAL Discontinued None No No
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/29/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2019 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

09/23/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

09/23/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/23/2019 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/23/2019 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

02/14/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/22/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/02/2010 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/03/2010 SUPPL-3 Labeling-Container/Carton Labels

Label is not available on this site.

10/25/2007 SUPPL-2 Labeling

Label is not available on this site.

10/25/2007 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

FENOFIBRATE

TABLET;ORAL; 54MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 210138 AJANTA PHARMA LTD
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 209950 AMNEAL PHARMS LLC
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 207803 AUSTARPHARMA
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 076509 IMPAX LABS
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 204019 LUPIN LTD
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 076520 MYLAN
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 210670 NUVO PHARM
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 209660 ORIT LABS LLC
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 076433 RHODES PHARMS
FENOFIBRATE FENOFIBRATE 54MG TABLET;ORAL Prescription No AB 076635 SUN PHARM INDS LTD

TABLET;ORAL; 160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 210138 AJANTA PHARMA LTD
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 209950 AMNEAL PHARMS LLC
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 207803 AUSTARPHARMA
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 076509 IMPAX LABS
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 204019 LUPIN LTD
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 076520 MYLAN
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 210670 NUVO PHARM
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 209660 ORIT LABS LLC
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 076433 RHODES PHARMS
FENOFIBRATE FENOFIBRATE 160MG TABLET;ORAL Prescription No AB 076635 SUN PHARM INDS LTD

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