Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202676
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription AB No No
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription AB No No
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;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
10/23/2012 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
05/15/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/18/2018 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

FENOFIBRATE (MICRONIZED)

CAPSULE;ORAL; 67MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 210705 AJANTA PHARMA LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 209504 AMERIGEN PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 207805 AUSTARPHARMA
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 205566 GLENMARK PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 075868 IMPAX LABS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 207378 INVAGEN PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 202676 MYLAN PHARMS INC
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 075753 RHODES PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 210782 TORRENT

CAPSULE;ORAL; 134MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 210705 AJANTA PHARMA LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 209504 AMERIGEN PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 207805 AUSTARPHARMA
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 205566 GLENMARK PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 075868 IMPAX LABS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 207378 INVAGEN PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 202676 MYLAN PHARMS INC
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 075753 RHODES PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 210782 TORRENT

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 210705 AJANTA PHARMA LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 209504 AMERIGEN PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 207805 AUSTARPHARMA
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 205566 GLENMARK PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 075868 IMPAX LABS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 207378 INVAGEN PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 202676 MYLAN PHARMS INC
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 075753 RHODES PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 210782 TORRENT

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