Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020762
Company: ORGANON LLC
Company: ORGANON LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NASONEX | MOMETASONE FUROATE | 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY, METERED;NASAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/01/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020762_s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/28/2022 | SUPPL-56 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020762s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020762Orig1s056ltr.pdf | |
| 09/09/2020 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020762s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020762Orig1s055ltr.pdf | |
| 06/22/2018 | SUPPL-53 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020672Orig1s052s053Ltr.pdf | |
| 06/22/2018 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020672Orig1s052s053Ltr.pdf | |
| 03/03/2015 | SUPPL-51 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020762Orig1s051.pdf |
| 10/27/2014 | SUPPL-50 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020762Orig1s050.pdf |
| 04/18/2014 | SUPPL-49 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/020762Orig1s049.pdf |
| 11/16/2012 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/2011 | SUPPL-44 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020762s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020762s044ltr.pdf | |
| 05/26/2010 | SUPPL-38 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020762s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020762s038ltr.pdf | |
| 12/15/2004 | SUPPL-23 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20762s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020762Orig1s023_FINAL_corrected.pdf | |
| 12/18/2003 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20762slr021_nasonex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20762slr021ltr.pdf | |
| 03/03/2003 | SUPPL-14 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20762slr014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020762_S014_NASONEX_AP.pdf |
| 09/13/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/2002 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-11 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20762s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20762se5011ltr.pdf | |
| 02/22/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/04/2000 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/25/2004 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20762s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020762_S007_NASONEX_AQUEOUS_NASAL_SPRAY.pdf | |
| 04/16/1999 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/02/1998 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/11/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1998 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20762s1ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20762-S001_Nasonex.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/28/2022 | SUPPL-56 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020762s056lbl.pdf | |
| 06/28/2022 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020762s056lbl.pdf | |
| 06/28/2022 | SUPPL-56 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020762s056lbl.pdf | |
| 09/09/2020 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020762s055lbl.pdf | |
| 06/22/2018 | SUPPL-53 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s053lbl.pdf | |
| 06/22/2018 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020762s052lbl.pdf | |
| 01/19/2011 | SUPPL-44 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020762s044lbl.pdf | |
| 05/26/2010 | SUPPL-38 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020762s038lbl.pdf | |
| 12/15/2004 | SUPPL-23 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s023lbl.pdf | |
| 08/25/2004 | SUPPL-7 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20762s007lbl.pdf | |
| 12/18/2003 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20762slr021_nasonex_lbl.pdf | |
| 07/17/2002 | SUPPL-11 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20762s11lbl.pdf |