Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021794
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACZONE DAPSONE 5% GEL;TOPICAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/07/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021794ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021794s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/03/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/09/2015 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021794Orig1s013ltr.pdf
11/08/2013 SUPPL-12 Labeling

Label is not available on this site.

10/03/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/31/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/26/2009 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/14/2008 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021794s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/09/2015 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf
03/26/2009 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/26/2009 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/14/2008 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf
07/07/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf

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