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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021415
Company: GALDERMA LABS LP

Products on NDA 021415

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METVIXIA	METHYL AMINOLEVULINATE HYDROCHLORIDE	EQ 16.8% BASE	CREAM;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021415

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21415lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21415ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021415s000_MetvixiaTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/2012	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021415s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021415Orig1s004ltr.pdf
06/26/2008	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021415s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021415s003ltr.pdf
05/31/2005	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021415s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021415s001ltr.pdf

Labels for NDA 021415

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/20/2012	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021415s004lbl.pdf
06/26/2008	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021415s003lbl.pdf
05/31/2005	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021415s001lbl.pdf
07/27/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21415lbl.pdf

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