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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202252
Company: APOTEX

Products on ANDA 202252

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE;ORAL	Prescription	AB	No	No
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202252

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2013	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2021	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/09/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/09/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/09/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/09/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202252

FENOFIBRATE (MICRONIZED)

CAPSULE;ORAL; 43MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANTARA (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE;ORAL	Prescription	Yes	AB	021695	LUPIN
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE;ORAL	Prescription	No	AB	202252	APOTEX
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE;ORAL	Prescription	No	AB	090859	CHARTWELL RX

CAPSULE;ORAL; 130MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANTARA (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE;ORAL	Prescription	Yes	AB	021695	LUPIN
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE;ORAL	Prescription	No	AB	202252	APOTEX
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE;ORAL	Prescription	No	AB	090859	CHARTWELL RX

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