Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201699
Company: CUBIST PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIFICID FIDAXOMICIN 200MG 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
05/27/2011 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201699s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201699s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201699Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2019 SUPPL-11 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201699Orig1s011ltr.pdf
03/15/2019 SUPPL-10 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201699Orig1s010ltr.pdf
02/24/2015 SUPPL-9 Efficacy-Pediatric Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201699Orig1s009ltr.pdf
11/18/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/06/2013 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/21/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/04/2013 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201699Orig1s004ltr_corrected.pdf
12/19/2012 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/05/2019 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf
04/05/2019 SUPPL-11 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s011lbl.pdf
03/15/2019 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf
03/15/2019 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201699s010lbl.pdf
04/04/2013 SUPPL-4 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201699s004lbl.pdf
05/27/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201699s000lbl.pdf

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