Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018117
Company: ABBVIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZMACORT TRIAMCINOLONE ACETONIDE 0.1MG/INH AEROSOL, METERED;INHALATION 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
04/23/1982 ORIG-1 Approval Type 3 - New Dosage Form 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
03/13/2008 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018117s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018117s042ltr.pdf
09/05/2006 SUPPL-37 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018117s037_ltr.pdf
12/23/2003 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr034_azmacort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr034ltr.pdf
12/18/2003 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr033_azmacort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr033ltr.pdf
09/04/2003 SUPPL-32 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr032_azmacort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr032ltr.pdf
08/17/2000 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/2007 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018117s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018117s030ltr.pdf
02/08/1999 SUPPL-29 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18117s029_azmacort_approv_prntlbl_medr_admindocs_corres.pdf
06/12/1997 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/02/1996 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/30/1996 SUPPL-26 Efficacy-New Dosing Regimen

Label is not available on this site.

11/21/1996 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/30/1992 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/27/1990 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

02/18/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/17/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/12/1992 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1990 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/1990 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/13/1989 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/03/1989 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1987 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/26/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1984 SUPPL-5 Labeling

Label is not available on this site.

03/13/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/13/1984 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1984 SUPPL-2 Labeling

Label is not available on this site.

03/12/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/13/2008 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018117s042lbl.pdf
04/13/2007 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018117s030lbl.pdf
12/23/2003 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr034_azmacort_lbl.pdf
12/18/2003 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr033_azmacort_lbl.pdf
09/04/2003 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr032_azmacort_lbl.pdf

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