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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204475
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOFIBRATE FENOFIBRATE 40MG TABLET;ORAL Prescription AB No No
FENOFIBRATE FENOFIBRATE 120MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/23/2016 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204475Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204475Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2022 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/04/2022 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/04/2022 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/23/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204475Orig1s000lbl.pdf

FENOFIBRATE

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE FENOFIBRATE 40MG TABLET;ORAL Prescription No AB 204475 MYLAN PHARMS INC

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE FENOFIBRATE 120MG TABLET;ORAL Prescription No AB 204475 MYLAN PHARMS INC
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