Drugs@FDA: FDA-Approved Drugs

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