Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021775
Company: CUBIST PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENTEREG ALVIMOPAN 12MG CAPSULE;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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

ENTEREG

CAPSULE;ORAL; 12MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALVIMOPAN ALVIMOPAN 12MG CAPSULE;ORAL Prescription No AB 208295 WATSON LABS TEVA
ENTEREG ALVIMOPAN 12MG CAPSULE;ORAL Prescription Yes AB 021775 CUBIST PHARMS

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