U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207378
Company: INVAGEN PHARMS
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
03/28/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/03/2021 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/15/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/18/2018 SUPPL-2 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 213842 ALEMBIC PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 209504 ANI PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE;ORAL Prescription No AB 212232 AUROBINDO PHARMA LTD
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 207805 REYOUNG
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 213842 ALEMBIC PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 209504 ANI PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE;ORAL Prescription No AB 212232 AUROBINDO PHARMA LTD
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 207805 REYOUNG
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 213842 ALEMBIC PHARMS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 209504 ANI PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 212232 AUROBINDO PHARMA LTD
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 207805 REYOUNG
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 075753 RHODES PHARMS
FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE;ORAL Prescription No AB 210782 TORRENT
Back to Top