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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021775
Company: CUBIST PHARMS

REMS

Summary Review

Products on NDA 021775

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENTEREG	ALVIMOPAN	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021775

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/20/2008	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/2008/021775lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021775s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021775_ENTEREGTOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021775s000_SUMR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2023	SUPPL-20	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021775Orig1s020ltr.pdf
11/17/2020	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021775s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021775Orig1s018ltr.pdf
10/10/2019	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021775s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021775Orig1s016ltr.pdf
12/19/2019	SUPPL-15	REMS - MODIFIED - D-N-A, REMS - MODIFIED - BIFURCATED	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021775Orig1s015ltr.pdf
05/18/2016	SUPPL-13	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021775Orig1s013ltr.pdf
05/29/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/18/2013	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021775s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021775Orig1s010ltr.pdf
10/21/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021775s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021775Orig1s008ltr.pdf
09/25/2012	SUPPL-7	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021775Orig1s007ltr.pdf
11/06/2009	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021775s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021775s004ltr.pdf
02/05/2009	SUPPL-1	Labeling, REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021775s001ltr.pdf

Labels for NDA 021775

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2020	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021775s018lbl.pdf
10/10/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021775s016lbl.pdf
10/18/2013	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021775s010lbl.pdf
10/21/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021775s008lbl.pdf
11/06/2009	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021775s004lbl.pdf
05/20/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021775lbl.pdf

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