Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022549
Company: GALEN UK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADASUVE LOXAPINE 10MG POWDER;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
12/21/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022549Orig1s006ltr.pdf
09/28/2016 SUPPL-5 Labeling-Patient Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022549Orig1s005ltr.pdf
12/09/2013 SUPPL-2 REMS-Assessment, REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022549Orig1s002ltr.pdf
12/21/2012 SUPPL-1 Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022549s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022549Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022549_adasuve_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022549Orig1s000SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf
09/28/2016 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf
09/28/2016 SUPPL-5 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf
12/21/2012 SUPPL-1 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022549s000lbl.pdf

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