Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 020762
Company: ORGANON LLC

Products on NDA 020762

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NASONEX	MOMETASONE FUROATE	0.05MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued	None	Yes	No

Showing 1 to 1 of 1 entries

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020762

Original Approvals or Tentative Approvals

CSV Excel Print

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
10/01/1997	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.

Showing 1 to 1 of 1 entries

Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
06/28/2022	SUPPL-56	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)
09/09/2020	SUPPL-55	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/22/2018	SUPPL-53	Labeling-Package Insert	Label (PDF) Letter (PDF)
06/22/2018	SUPPL-52	Labeling-Package Insert	Label (PDF) Letter (PDF)
03/03/2015	SUPPL-51	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.
10/27/2014	SUPPL-50	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.
04/18/2014	SUPPL-49	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.
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)
05/26/2010	SUPPL-38	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
12/15/2004	SUPPL-23	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)
08/25/2004	SUPPL-7	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF) Review (PDF)
12/18/2003	SUPPL-21	Labeling	Label (PDF) Letter (PDF)
03/03/2003	SUPPL-14	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.
09/13/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
07/17/2002	SUPPL-11	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
01/11/2002	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
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.
12/02/1999	SUPPL-4	Efficacy-New Indication		Label is not available on this site.
04/16/1999	SUPPL-6	Manufacturing (CMC)-Control		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.
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.

Showing 1 to 25 of 25 entries

Labels for NDA 020762

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert
06/28/2022	SUPPL-56	Labeling-Package Insert	Label (PDF)
06/28/2022	SUPPL-56	Labeling-Patient Package Insert	Label (PDF)
06/28/2022	SUPPL-56	Labeling-Container/Carton Labels	Label (PDF)
09/09/2020	SUPPL-55	Labeling-Package Insert	Label (PDF)
06/22/2018	SUPPL-53	Labeling-Package Insert	Label (PDF)
06/22/2018	SUPPL-52	Labeling-Package Insert	Label (PDF)
01/19/2011	SUPPL-44	Efficacy-New Indication	Label (PDF)
05/26/2010	SUPPL-38	Efficacy-New Patient Population	Label (PDF)
12/15/2004	SUPPL-23	Efficacy-New Indication	Label (PDF)
08/25/2004	SUPPL-7	Manufacturing (CMC)-Formulation	Label (PDF)
12/18/2003	SUPPL-21	Labeling	Label (PDF)
07/17/2002	SUPPL-11	Efficacy-New Patient Population	Label (PDF)

Showing 1 to 12 of 12 entries