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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022203
Company: MYLAN SPECIALITY LP

Summary Review

Products on NDA 022203

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASTEPRO	AZELASTINE HYDROCHLORIDE	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED;NASAL	Discontinued	None	Yes	No
ASTEPRO	AZELASTINE HYDROCHLORIDE	0.2055MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022203

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
06/28/2021	SUPPL-18	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022203s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022203Orig1s018ltr.pdf
09/06/2018	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022203s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022203Orig1s015Ltr.pdf
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

Labels for NDA 022203

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2021	SUPPL-18	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022203s018lbl.pdf
06/28/2021	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022203s018lbl.pdf
09/06/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022203s015lbl.pdf
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

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