Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020428
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZELEX AZELAIC ACID 20% CREAM;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
09/13/1995 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/10/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20428slr016_azelex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20428slr016ltr.pdf
02/19/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/27/2001 SUPPL-13 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20428s13lbl.pdf
04/05/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1999 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/10/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/04/1998 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1997 SUPPL-7 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20428S1S7_Azelex.pdf
09/04/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/27/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1996 SUPPL-1 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20428S1S7_Azelex.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/10/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20428slr016_azelex_lbl.pdf
04/27/2001 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20428s13lbl.pdf

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