Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022007
Company: MYLAN SPECLT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERFOROMIST FORMOTEROL FUMARATE 0.02MG/2ML SOLUTION;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
05/11/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022007s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022007_perforomist_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/29/2019 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022007s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022007Orig1s015ltr.pdf
10/17/2018 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022007Orig1s014ltr.pdf
11/30/2017 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022007s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022007Orig1s012ltr.pdf
03/19/2014 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/25/2012 SUPPL-8 REMS-Assessment Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007Orig1s007,s008ltr.pdf
09/25/2012 SUPPL-7 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007Orig1s007,s008ltr.pdf
01/11/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022007s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022007s006ltr.pdf
02/01/2011 SUPPL-5 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022007s005ltr.pdf
06/02/2010 SUPPL-4 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022007s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022007s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/29/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022007s015lbl.pdf
10/17/2018 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf
10/17/2018 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022007s014lbl.pdf
11/30/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022007s012lbl.pdf
01/11/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022007s006lbl.pdf
06/02/2010 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022007s004lbl.pdf
05/11/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022007lbl.pdf

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