Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022033
Company: JAZZ PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUVOX CR FLUVOXAMINE MALEATE 100MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
LUVOX CR FLUVOXAMINE MALEATE 150MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued 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
02/28/2008 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022033s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022033TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022033s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022033Orig1s011ltr.pdf
07/18/2014 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022033s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022033Orig1s010ltr.pdf
11/30/2012 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022033s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022033Orig1s009ltr.pdf
05/09/2011 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf
05/09/2011 SUPPL-6 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf
05/09/2011 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022033s003,s006,s007ltr.pdf
02/24/2009 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022033s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021519s001,022033s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022033s011lbl.pdf
07/18/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022033s010lbl.pdf
11/30/2012 SUPPL-9 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022033s009lbl.pdf
11/30/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022033s009lbl.pdf
05/09/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s007lbl.pdf
05/09/2011 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s006lbl.pdf
05/09/2011 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022033s003lbl.pdf
02/24/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022033s002lbl.pdf
02/28/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022033lbl.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