Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021861
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PATANASE OLOPATADINE HYDROCHLORIDE 0.665MG/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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

PATANASE

SPRAY, METERED;NASAL; 0.665MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 091572 APOTEX INC
OLOPATADINE HYDROCHLORIDE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 202853 PERRIGO ISRAEL
PATANASE OLOPATADINE HYDROCHLORIDE 0.665MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 021861 NOVARTIS

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