Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 203858
Company: AEGERION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JUXTAPID LOMITAPIDE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription None Yes No
JUXTAPID LOMITAPIDE MESYLATE EQ 10MG BASE CAPSULE;ORAL Prescription None Yes No
JUXTAPID LOMITAPIDE MESYLATE EQ 20MG BASE CAPSULE;ORAL Prescription None Yes No
JUXTAPID LOMITAPIDE MESYLATE EQ 30MG BASE CAPSULE;ORAL Prescription None Yes No
JUXTAPID LOMITAPIDE MESYLATE EQ 40MG BASE CAPSULE;ORAL Prescription None Yes No
JUXTAPID LOMITAPIDE MESYLATE EQ 60MG BASE CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203858Orig1s000ltr_replace.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/2038858_juxtapid_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/2018 SUPPL-18 REMS - PROPOSAL - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203858Orig1s018ltr.pdf
08/02/2017 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s017ltr.pdf
01/03/2017 SUPPL-16 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s013,s016ltr.pdf
05/23/2016 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s015ltr.pdf
07/11/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/03/2017 SUPPL-13 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203858Orig1s013,s016ltr.pdf
03/08/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203858Orig1s012ltr.pdf
04/24/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/23/2015 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203858s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203858Orig1s010ltr.pdf
08/08/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s009ltr.pdf
11/11/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/18/2014 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203858Orig1s006ltr.pdf
04/23/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/17/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/10/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203858s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s002ltr.pdf
08/13/2013 SUPPL-1 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203858Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/02/2017 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203858s017lbl.pdf
05/23/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s015lbl.pdf
03/08/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203858s012lbl.pdf
04/23/2015 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203858s010lbl.pdf
08/08/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s009lbl.pdf
02/18/2014 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203858s006lbl.pdf
04/10/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203858s002lbl.pdf
12/21/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203858s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English