Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202811
Company: FOREST LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LINZESS LINACLOTIDE 145MCG CAPSULE;ORAL Prescription None Yes No
LINZESS LINACLOTIDE 290MCG CAPSULE;ORAL Prescription None Yes Yes
LINZESS LINACLOTIDE 72MCG 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
08/30/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202811s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202811Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202811Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2017 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202811Orig1s013ltr.pdf
01/06/2017 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/31/2016 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s011ltr.pdf
01/25/2017 SUPPL-10 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202811Orig1s010ltr.pdf
11/23/2015 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202811s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202811Orig1s009ltr.pdf
05/18/2016 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/06/2016 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202811Orig1s007ltr.pdf
01/05/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/01/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/09/2014 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202811s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202811Orig1s004ltr.pdf
08/08/2013 SUPPL-3 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202811s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202811Orig1s003ltr.pdf
11/08/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/11/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/08/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf
03/08/2017 SUPPL-13 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf
01/25/2017 SUPPL-10 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s010lbl.pdf
08/31/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s011lbl.pdf
08/31/2016 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s011lbl.pdf
04/06/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202811s007lbl.pdf
11/23/2015 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202811s009lbl.pdf
11/23/2015 SUPPL-9 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202811s009lbl.pdf
07/09/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202811s004lbl.pdf
08/08/2013 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202811s003lbl.pdf
08/30/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202811s000lbl.pdf

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