Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021247
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AEROSPAN HFA FLUNISOLIDE 0.078MG/INH AEROSOL, METERED;INHALATION Prescription None 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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