Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022000
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIALDA MESALAMINE 1.2GM TABLET, DELAYED RELEASE;ORAL Prescription AB 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
01/16/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022000s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022000s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/27/2017 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020049Orig1s030,022000Orig1s016ltr.pdf
08/22/2017 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022000Orig1s015ltr.pdf
10/16/2014 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022000s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022000Orig1s013ltr.pdf
03/14/2014 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

12/16/2013 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s011ltr.pdf
08/09/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf
08/28/2013 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s009ltr.pdf
08/09/2013 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022000Orig1s008,022000Orig1s010ltr.pdf
07/14/2011 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022000s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022000s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022000Orig1s005.pdf
09/22/2010 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022000s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022000s003ltr.pdf
10/30/2009 SUPPL-2 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022000s002lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/22/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s015lbl.pdf
07/27/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022000s016lbl.pdf
10/16/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022000s013lbl.pdf
12/16/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s011lbl.pdf
08/28/2013 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000Orig1s009lbl.pdf
08/09/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf
08/09/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022000s008s010lbl.pdf
07/14/2011 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022000s005lbl.pdf
09/22/2010 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022000s003lbl.pdf
10/30/2009 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022000s002lbl.pdf
01/16/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022000lbl.pdf

LIALDA

TABLET, DELAYED RELEASE;ORAL; 1.2GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIALDA MESALAMINE 1.2GM TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 022000 SHIRE
MESALAMINE MESALAMINE 1.2GM TABLET, DELAYED RELEASE;ORAL Prescription No AB 091640 ZYDUS PHARMS USA INC

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