Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022436
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XERESE ACYCLOVIR; HYDROCORTISONE 5%;1% CREAM;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
07/31/2009 ORIG-1 Approval Type 4 - New Combination STANDARD Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022436s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022436_acyclovir_hydrocortisone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022436s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/14/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/24/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/22/2014 SUPPL-4 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022436s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022436Orig1s004ltr.pdf
05/12/2010 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Proprietary Name Change Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022436s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022436s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/22/2014 SUPPL-4 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022436s004lbl.pdf
05/12/2010 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022436s001lbl.pdf
05/12/2010 SUPPL-1 Labeling-Proprietary Name Change Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022436s001lbl.pdf

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