Drugs@FDA: FDA-Approved Drugs
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 |