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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213842
Company: ALEMBIC

Products on ANDA 213842

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213842

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/19/2020	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
06/03/2021	SUPPL-1	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213842

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	213842	ALEMBIC
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE;ORAL	Prescription	No	AB	209504	ANI PHARMS
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE;ORAL	Prescription	No	AB	212232	AUROBINDO PHARMA LTD
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE;ORAL	Prescription	No	AB	205566	GLENMARK PHARMS LTD
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE;ORAL	Prescription	No	AB	207378	INVAGEN PHARMS
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE;ORAL	Prescription	No	AB	207805	REYOUNG
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	213842	ALEMBIC
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE;ORAL	Prescription	No	AB	209504	ANI PHARMS
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE;ORAL	Prescription	No	AB	212232	AUROBINDO PHARMA LTD
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE;ORAL	Prescription	No	AB	205566	GLENMARK PHARMS LTD
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE;ORAL	Prescription	No	AB	207378	INVAGEN PHARMS
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE;ORAL	Prescription	No	AB	207805	REYOUNG
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	213842	ALEMBIC
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE;ORAL	Prescription	No	AB	209504	ANI PHARMS
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE;ORAL	Prescription	No	AB	212232	AUROBINDO PHARMA LTD
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE;ORAL	Prescription	No	AB	205566	GLENMARK PHARMS LTD
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE;ORAL	Prescription	No	AB	207378	INVAGEN PHARMS
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE;ORAL	Prescription	No	AB	207805	REYOUNG
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE;ORAL	Prescription	No	AB	075753	RHODES PHARMS
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE;ORAL	Prescription	No	AB	210782	TORRENT

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