Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200796
Company: ARBOR PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EDARBI AZILSARTAN KAMEDOXOMIL EQ 40MG MEDOXOMIL TABLET;ORAL Prescription None Yes No
EDARBI AZILSARTAN KAMEDOXOMIL EQ 80MG MEDOXOMIL TABLET;ORAL Prescription None 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
02/25/2011 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200796sOrig1s000_Edarbi_TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2016 SUPPL-9 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200796Orig1s009ltr.pdf
03/24/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/23/2014 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200796s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s006ltr.pdf
04/18/2014 SUPPL-5 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200796Orig1s005,202331Orig1s005ltr.pdf
07/29/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/04/2012 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200796s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200796Orig1s003ltr_replacement.pdf
12/14/2011 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s002ltr.pdf
04/12/2011 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200796s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/23/2014 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200796s006lbl.pdf
10/04/2012 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200796s003lbl.pdf
12/14/2011 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s002lbl.pdf
04/12/2011 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s001lbl.pdf
02/25/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200796s000lbl.pdf

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