An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021247
Company: MYLAN SPECIALITY LP

Products on NDA 021247

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AEROSPAN HFA	FLUNISOLIDE	0.078MG/INH	AEROSOL, METERED;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021247

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021247LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021247s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021247_aerospan_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2018	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021247s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021247Orig1s017ltr.pdf
11/17/2017	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021247Orig1s016ltr.pdf
06/23/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021247Orig1s015ltr.pdf
04/22/2016	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/09/2016	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/09/2015	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/14/2014	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/09/2013	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/30/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/28/2013	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021247s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021247Orig1s008ltr.pdf
11/16/2012	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021247s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021247Orig1s007ltr.pdf

Labels for NDA 021247

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2018	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021247s017lbl.pdf
11/17/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s016lbl.pdf
06/23/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021247s015lbl.pdf
08/28/2013	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021247s008lbl.pdf
11/16/2012	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021247s007lbl.pdf
01/27/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021247LBL.pdf

Top