Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020468
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NASACORT ALLERGY 24 HOUR TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter 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
05/20/1996 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/17/2018 SUPPL-46 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020468Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020468Orig1s046ltr.pdf
01/19/2018 SUPPL-44 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020468Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020468Orig1s044ltr.pdf
09/22/2016 SUPPL-42 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020468Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020468Orig1s042ltr.pdf
03/22/2016 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

06/18/2015 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020468Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020468Orig1s040ltr.pdf
09/19/2014 SUPPL-39 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020468Orig1s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020468Orig1s039ltr.pdf
06/12/2014 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/07/2013 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

05/24/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

10/11/2013 SUPPL-35 Efficacy-Rx To OTC Switch Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s035ltr.pdf
07/02/2013 SUPPL-34 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s033,s034ltr.pdf
07/02/2013 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020468Orig1s033,s034ltr.pdf
09/19/2008 SUPPL-24 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020468s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020468s024ltr.pdf
12/07/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/08/2004 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20468slr013_nasacort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20468slr013ltr.pdf
12/23/2003 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr012_nasacort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20468slr012ltr.pdf
12/17/2003 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr011_nasacort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20468slr011ltr.pdf
05/06/2002 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/12/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/17/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1997 SUPPL-2 Efficacy-New Indication

Label is not available on this site.

08/23/1996 SUPPL-1 Manufacturing (CMC)-Control Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020468_s001_NASACORT AQ.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/17/2018 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020468Orig1s046lbl.pdf
01/19/2018 SUPPL-44 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020468Orig1s044lbl.pdf
09/22/2016 SUPPL-42 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020468Orig1s042lbl.pdf
06/18/2015 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020468Orig1s040lbl.pdf
09/19/2014 SUPPL-39 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020468Orig1s039lbl.pdf
10/11/2013 SUPPL-35 Efficacy-Rx To OTC Switch Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468Orig1s035lbl.pdf
07/02/2013 SUPPL-34 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf
07/02/2013 SUPPL-33 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020468s033s034lbl.pdf
09/19/2008 SUPPL-24 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020468s024lbl.pdf
03/08/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20468slr013_nasacort_lbl.pdf
12/23/2003 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr012_nasacort_lbl.pdf
12/17/2003 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20468slr011_nasacort_lbl.pdf

NASACORT ALLERGY 24 HOUR

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SPRAY, METERED;NASAL; 0.055MG/SPRAY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NASACORT ALLERGY 24 HOUR TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter Yes 020468 SANOFI AVENTIS US
TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.055MG/SPRAY SPRAY, METERED;NASAL Over-the-counter No 078104 PERRIGO ISRAEL

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