Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022266
Company: BDSI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONSOLIS FENTANYL CITRATE EQ 0.2MG BASE FILM;BUCCAL Discontinued None No No
ONSOLIS FENTANYL CITRATE EQ 0.4MG BASE FILM;BUCCAL Discontinued None No No
ONSOLIS FENTANYL CITRATE EQ 0.6MG BASE FILM;BUCCAL Discontinued None No No
ONSOLIS FENTANYL CITRATE EQ 0.8MG BASE FILM;BUCCAL Discontinued None No No
ONSOLIS FENTANYL CITRATE EQ 1.2MG BASE FILM;BUCCAL Discontinued None No 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
07/16/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022266s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266_onsolis_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266s000_SumR_P1.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022266Orig1s023ltr.pdf
09/07/2017 SUPPL-19 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022266Orig1s019ltr.pdf
12/16/2016 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022266Orig1s017,s018ltr.pdf
12/16/2016 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022266Orig1s017,s018ltr.pdf
08/11/2015 SUPPL-15 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022266s015lbl.pdf
12/24/2014 SUPPL-14 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022266s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022266Orig1s014ltr.pdf
11/07/2013 SUPPL-12 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022266Orig1s012ltr.pdf
06/05/2012 SUPPL-9 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022266s009ltr.pdf
12/28/2011 SUPPL-8 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022266s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022266s008ltr.pdf
07/01/2010 SUPPL-1 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022266s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022266s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-23 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf
10/07/2019 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf
12/16/2016 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf
12/16/2016 SUPPL-17 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf
12/16/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf
08/11/2015 SUPPL-15 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022266s015lbl.pdf
12/24/2014 SUPPL-14 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022266s014lbl.pdf
06/05/2012 SUPPL-9 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf
12/28/2011 SUPPL-8 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022266s008lbl.pdf
07/01/2010 SUPPL-1 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022266s001lbl.pdf
07/16/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000lbl.pdf

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