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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022436
Company: BAUSCH

Summary Review

Products on NDA 022436

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022436

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
12/11/2019	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022436s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022436Orig1s010ltr.pdf
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

Labels for NDA 022436

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022436s010lbl.pdf
12/11/2019	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022436s010lbl.pdf
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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