Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203567
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JUBLIA EFINACONAZOLE 10% SOLUTION;TOPICAL 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
06/06/2014 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/2014/203567s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203567Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567_jublia_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2016 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203567s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203567Orig1s006ltr.pdf
04/01/2016 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/05/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/26/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/27/2015 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203567s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203567Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/22/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203567s006lbl.pdf
02/27/2015 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203567s002lbl.pdf
06/06/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203567s000lbl.pdf

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