Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211080
Company: PRINSTON INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription AB No No
FENOFIBRATE FENOFIBRATE 145MG 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
08/28/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

FENOFIBRATE

TABLET;ORAL; 48MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 210476 ALEMBIC PHARMS LTD
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 209951 AMNEAL PHARMS LLC
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 205118 AUROBINDO PHARMA LTD
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 208709 CIPLA
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 204598 HETERO LABS LTD III
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 090856 LUPIN LTD
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 202856 MYLAN PHARMS INC
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 211080 PRINSTON INC
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 200884 SUN PHARM
FENOFIBRATE FENOFIBRATE 48MG TABLET;ORAL Prescription No AB 090715 VALEANT PHARMS NORTH
TRICOR FENOFIBRATE 48MG TABLET;ORAL Prescription Yes AB 021656 ABBVIE

TABLET;ORAL; 145MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 210476 ALEMBIC PHARMS LTD
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 209951 AMNEAL PHARMS LLC
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 205118 AUROBINDO PHARMA LTD
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 208709 CIPLA
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 204598 HETERO LABS LTD III
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 090856 LUPIN LTD
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 202856 MYLAN PHARMS INC
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 211080 PRINSTON INC
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 200884 SUN PHARM
FENOFIBRATE FENOFIBRATE 145MG TABLET;ORAL Prescription No AB 090715 VALEANT PHARMS NORTH
TRICOR FENOFIBRATE 145MG TABLET;ORAL Prescription Yes AB 021656 ABBVIE

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