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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021695
Company: LUPIN

Products on NDA 021695

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ANTARA (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE;ORAL	Prescription	AB	Yes	No
ANTARA (MICRONIZED)	FENOFIBRATE	87MG	CAPSULE;ORAL	Discontinued	None	No	No
ANTARA (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes
ANTARA (MICRONIZED)	FENOFIBRATE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
ANTARA (MICRONIZED)	FENOFIBRATE	90MG	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021695

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021695lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021695ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021695s000_AntaraTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2021	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021695s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021695Orig1s022ltr.pdf
05/15/2019	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021695s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021695Orig1s020ltr.pdf
11/07/2018	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021695s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021695Orig1s019ltr.pdf
02/04/2019	SUPPL-18		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021695s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021695Orig1s018ltr.pdf
05/18/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021695s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021695Orig1s017ltr.pdf
09/11/2017	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021695s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021695Orig1s016ltr.pdf
11/29/2016	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/09/2016	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/31/2015	SUPPL-12	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021695s012lbl.pdf
09/04/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/19/2012	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021695Orig1s010ltr.pdf
10/18/2013	SUPPL-9	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021695s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021695Orig1s009ltr.pdf
03/01/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021695s008ltr.pdf
06/03/2008	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021695s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021695s006ltr.pdf
10/21/2005	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021695s001ltr.pdf

Labels for NDA 021695

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021695s022lbl.pdf
05/15/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021695s020lbl.pdf
02/04/2019	SUPPL-18	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021695s018lbl.pdf
11/07/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021695s019lbl.pdf
05/18/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021695s017lbl.pdf
09/11/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021695s016lbl.pdf
08/31/2015	SUPPL-12	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021695s012lbl.pdf
10/18/2013	SUPPL-9	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021695s009lbl.pdf
12/19/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s010lbl.pdf
03/01/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021695s008lbl.pdf
06/03/2008	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021695s006lbl.pdf
11/30/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021695lbl.pdf

Therapeutic Equivalents for NDA 021695

ANTARA (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	FENOFIBRATE	43MG	CAPSULE;ORAL	Prescription	No	AB	201748	SUN PHARM INDS LTD
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE;ORAL	Prescription	No	AB	202252	APOTEX
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE;ORAL	Prescription	No	AB	090859	DR REDDYS LABS SA

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	FENOFIBRATE	130MG	CAPSULE;ORAL	Prescription	No	AB	201748	SUN PHARM INDS LTD
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE;ORAL	Prescription	No	AB	202252	APOTEX
FENOFIBRATE (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE;ORAL	Prescription	No	AB	090859	DR REDDYS LABS SA

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