Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020468
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
| 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 | CHATTEM SANOFI |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.055MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 214615 | APOTEX |
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.055MG/SPRAY | SPRAY, METERED;NASAL | Over-the-counter | No | 078104 | PERRIGO PHARMA INTL |