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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208705
Company: ALEMBIC PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription AB No No
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG 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
05/12/2017 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
09/19/2019 SUPPL-11 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

09/19/2019 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/19/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

FENOFIBRIC ACID

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
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 213450 MICRO LABS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 210469 TWI PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 212562 YICHANG HUMANWELL
TRILIPIX CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 022224 ABBVIE

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
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 213450 MICRO LABS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 210469 TWI PHARMS
FENOFIBRIC ACID CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription No AB 212562 YICHANG HUMANWELL
TRILIPIX CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID CAPSULE, DELAYED RELEASE;ORAL Prescription Yes AB 022224 ABBVIE
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