Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021695
Company: LUPIN ATLANTIS
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 CAPSULE;ORAL Prescription None Yes No
ANTARA (MICRONIZED) FENOFIBRATE 90MG CAPSULE;ORAL Prescription None Yes 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 ATLANTIS
FENOFIBRATE FENOFIBRATE 43MG CAPSULE;ORAL Prescription No AB 201748 SUN PHARM INDS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 43MG CAPSULE;ORAL Prescription No AB 202252 APOTEX INC
FENOFIBRATE (MICRONIZED) FENOFIBRATE 43MG CAPSULE;ORAL Prescription No AB 090859 DR REDDYS LABS SA
FENOFIBRATE (MICRONIZED) FENOFIBRATE 43MG CAPSULE;ORAL Prescription No AB 202579 MYLAN PHARMS INC

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 ATLANTIS
FENOFIBRATE FENOFIBRATE 130MG CAPSULE;ORAL Prescription No AB 201748 SUN PHARM INDS LTD
FENOFIBRATE (MICRONIZED) FENOFIBRATE 130MG CAPSULE;ORAL Prescription No AB 202252 APOTEX INC
FENOFIBRATE (MICRONIZED) FENOFIBRATE 130MG CAPSULE;ORAL Prescription No AB 090859 DR REDDYS LABS SA
FENOFIBRATE (MICRONIZED) FENOFIBRATE 130MG CAPSULE;ORAL Prescription No AB 202579 MYLAN PHARMS INC

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