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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202811
Company: ABBVIE

Medication Guide

Summary Review

Products on NDA 202811

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINZESS	LINACLOTIDE	145MCG	CAPSULE;ORAL	Prescription	AB	Yes	Yes
LINZESS	LINACLOTIDE	290MCG	CAPSULE;ORAL	Prescription	AB	Yes	No
LINZESS	LINACLOTIDE	72MCG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202811

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
06/12/2023	SUPPL-21	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202811Orig1s021ltr.pdf
08/24/2021	SUPPL-18	Labeling-Medication Guide, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202811Orig1s018ltr.pdf
04/12/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202811Orig1s017ltr.pdf
09/22/2020	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202811s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202811Orig1s016ltr.pdf
03/08/2017	SUPPL-13	Labeling-Patient Package Insert, Labeling-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) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202811Orig1s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/202811Orig1s010.pdf
11/23/2015	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert	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.

Labels for NDA 202811

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2023	SUPPL-21	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf
08/24/2021	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s018lbl.pdf
08/24/2021	SUPPL-18	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s018lbl.pdf
04/12/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s017lbl.pdf
09/22/2020	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202811s016lbl.pdf
03/08/2017	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf
03/08/2017	SUPPL-13	Labeling-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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202811s009lbl.pdf
11/23/2015	SUPPL-9	Labeling-Package Insert	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

Therapeutic Equivalents for NDA 202811

LINZESS

CAPSULE;ORAL; 145MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LINZESS	LINACLOTIDE	145MCG	CAPSULE;ORAL	Prescription	Yes	AB	202811	ABBVIE

CAPSULE;ORAL; 290MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LINZESS	LINACLOTIDE	290MCG	CAPSULE;ORAL	Prescription	Yes	AB	202811	ABBVIE

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