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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022563
Company: MAYNE PHARMA

Summary Review

Products on NDA 022563

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SORILUX	CALCIPOTRIENE	0.005%	AEROSOL, FOAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022563

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2010	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022563s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022563s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563_sorilux_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2019	SUPPL-8	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022563Orig1s007, s008.pdf
11/05/2019	SUPPL-7	Efficacy-New Patient Population	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022563Orig1s007,%20s008.pdf
05/06/2019	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022563s006lbl.pdf
07/10/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/27/2012	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022563Orig1s002ltr.pdf
04/21/2011	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022563s001ltr.pdf

Labels for NDA 022563

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/06/2019	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022563s006lbl.pdf
09/27/2012	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf
04/21/2011	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf
10/06/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022563s000lbl.pdf

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