Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210670
Company: NUVO PHARM
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 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
09/06/2019 ORIG-1 Approval STANDARD

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

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