Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022087
Company: GALDERMA LABS LP

• Summary Review

Products on NDA 22087

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VECTICAL	CALCITRIOL	3MCG/GM	OINTMENT;TOPICAL	Prescription	None	Yes	Yes

Labels for NDA 022087

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2020	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022087s009lbl.pdf
01/23/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022087lbl.pdf