AEROSPAN HFA از شرکت MYLAN SPECIALITY LP

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AEROSPAN HFA از شرکت MYLAN SPECIALITY LP

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 Discontinued

None

Yes No
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

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
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