Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201573
Company: ANCHEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription AB No No
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;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
07/18/2013 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201573Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201573Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/06/2015 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/18/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201573Orig1s000lbl.pdf

FENOFIBRIC ACID

CAPSULE, DELAYED RELEASE;ORAL; EQ 135MG FENOFIBRIC ACID
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200920 ACTAVIS ELIZABETH
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 208705 ALEMBIC PHARMS LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 201573 ANCHEN PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 212598 AUROBINDO PHARMA LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 211626 GRAVITI PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200264 IMPAX LABS INC
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200750 LUPIN LTD
TRILIPIX CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 022224 ABBVIE

CAPSULE, DELAYED RELEASE;ORAL; EQ 45MG FENOFIBRIC ACID
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200920 ACTAVIS ELIZABETH
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 208705 ALEMBIC PHARMS LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 201573 ANCHEN PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 212598 AUROBINDO PHARMA LTD
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 211626 GRAVITI PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200264 IMPAX LABS INC
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 200750 LUPIN LTD
TRILIPIX CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 022224 ABBVIE

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