Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

• Summary Review

Products on NDA 022087

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022087

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/2009	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022087s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022087_vectical_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022087s000_SumR.pdf

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022087s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022087Orig1s009ltr.pdf

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