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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021908
Company: SUCAMPO PHARMA LLC

Summary Review

Products on NDA 021908

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMITIZA	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	AB	Yes	Yes
AMITIZA	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021908

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
11/30/2020	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021908s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021908Orig1s018ltr.pdf
04/26/2018	SUPPL-16	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021908s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021908Orig1s016Ltr.pdf
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

Labels for NDA 021908

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2020	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021908s018lbl.pdf
04/26/2018	SUPPL-16	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021908s016lbl.pdf
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

Therapeutic Equivalents for NDA 021908

AMITIZA

CAPSULE;ORAL; 24MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMITIZA	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	Yes	AB	021908	SUCAMPO PHARMA LLC
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	209450	AMNEAL
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	206994	DR REDDYS
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	209920	TEVA PHARMS USA INC
LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE;ORAL	Prescription	No	AB	214131	ZYDUS PHARMS

CAPSULE;ORAL; 8MCG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMITIZA	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	Yes	AB	021908	SUCAMPO PHARMA LLC
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	209450	AMNEAL
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	206994	DR REDDYS
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	209920	TEVA PHARMS USA INC
LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE;ORAL	Prescription	No	AB	214131	ZYDUS PHARMS

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