Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075753
Company: RHODES 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
04/09/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75753.ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/15/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

05/18/2018 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/18/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/07/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/075753s005lbl.pdf
07/31/2003 SUPPL-3 Labeling

Label is not available on this site.

07/31/2003 SUPPL-2 Labeling

Label is not available on this site.

09/03/2002 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/07/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/075753s005lbl.pdf

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English