Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022203
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ASTEPRO AZELASTINE HYDROCHLORIDE EQ 0.125MG BASE/SPRAY SPRAY, METERED;NASAL Discontinued None No No
ASTEPRO AZELASTINE HYDROCHLORIDE EQ 0.1876MG 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
10/15/2008 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review
Summary Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022203s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022203s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022203s000SUMR.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/20/2015 SUPPL-11 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011ltr.pdf
02/20/2015 SUPPL-10 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011ltr.pdf
03/13/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/30/2013 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022203s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022203Orig1s008ltr.pdf
01/19/2011 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022203s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022203s006ltr.pdf
08/31/2009 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022203s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022203s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/20/2015 SUPPL-11 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf
02/20/2015 SUPPL-10 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022203s010s011lbl.pdf
08/30/2013 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022203s008lbl.pdf
01/19/2011 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022203s006lbl.pdf
08/31/2009 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022203s003lbl.pdf

ASTEPRO

SPRAY, METERED;NASAL; EQ 0.1876MG BASE/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ASTEPRO AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 022203 MYLAN SPECIALITY LP
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 201846 APOTEX INC
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 202743 PERRIGO ISRAEL
AZELASTINE HYDROCHLORIDE AZELASTINE HYDROCHLORIDE EQ 0.1876MG BASE/SPRAY SPRAY, METERED;NASAL Prescription No AB 207243 WEST-WARD PHARMS INT

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