Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020762
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NASONEX MOMETASONE FUROATE EQ 0.05MG BASE/SPRAY SPRAY, METERED;NASAL Prescription AB 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
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
06/22/2018 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
06/22/2018 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

NASONEX

SPRAY, METERED;NASAL; EQ 0.05MG BASE/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MOMETASONE FUROATE MOMETASONE FUROATE EQ 0.05MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 207989 AMNEAL PHARMS
MOMETASONE FUROATE MOMETASONE FUROATE EQ 0.05MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 091161 APOTEX INC
NASONEX MOMETASONE FUROATE EQ 0.05MG BASE/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020762 MERCK SHARP DOHME

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English