Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021908
Company: SUCAMPO PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMITIZA LUBIPROSTONE 24MCG CAPSULE;ORAL Prescription None Yes Yes
AMITIZA LUBIPROSTONE 8MCG 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
01/31/2006 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021908s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021908s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021908s000_AmitizaTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2017 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021908s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021908Orig1s015ltr.pdf
10/11/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021908s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021908Orig1s013ltr.pdf
08/19/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/19/2013 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021908s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021908Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021908Orig1s011.pdf
11/26/2012 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021908s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021908Orig1s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021908Orig1s010.pdf
02/24/2011 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021908s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021908s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021908Orig1s008.pdf
04/29/2008 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021908s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021908se1-005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021908s005TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021908se1-005_SUMR.pdf
05/16/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021908s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021908s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/01/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021908s015lbl.pdf
10/11/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021908s013lbl.pdf
04/19/2013 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021908s011lbl.pdf
11/26/2012 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021908s010lbl.pdf
02/24/2011 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021908s008lbl.pdf
04/29/2008 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021908s005lbl.pdf
05/16/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021908s004lbl.pdf
01/31/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021908s000lbl.pdf

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