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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021861
Company: NOVARTIS

Products on NDA 021861

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PATANASE	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021861

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2008	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021861lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021861s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021861s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2021	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021861s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021861Orig1s015ltr.pdf
07/27/2016	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/27/2015	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021861s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021861Orig1s011ltr.pdf
02/22/2012	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021861s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021861s009ltr.pdf
03/31/2010	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021861s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021861s008ltr.pdf
12/01/2009	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021861s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021861s002ltr.pdf
06/17/2009	SUPPL-1	Efficacy-Labeling Change With Clinical Data		Label is not available on this site.

Labels for NDA 021861

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021861s015lbl.pdf
10/27/2015	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021861s011lbl.pdf
02/22/2012	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021861s009lbl.pdf
03/31/2010	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021861s008lbl.pdf
12/01/2009	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021861s002lbl.pdf
04/15/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021861lbl.pdf

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