Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202788
Company: BTCP PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUBSYS FENTANYL 0.1MG SPRAY;SUBLINGUAL Prescription None Yes No
SUBSYS FENTANYL 0.2MG SPRAY;SUBLINGUAL Prescription None Yes No
SUBSYS FENTANYL 0.4MG SPRAY;SUBLINGUAL Prescription None Yes Yes
SUBSYS FENTANYL 0.6MG SPRAY;SUBLINGUAL Prescription None Yes No
SUBSYS FENTANYL 0.8MG SPRAY;SUBLINGUAL Prescription None Yes No
SUBSYS FENTANYL 1.2MG SPRAY;SUBLINGUAL Prescription None Yes No
SUBSYS FENTANYL 1.6MG SPRAY;SUBLINGUAL Prescription 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
01/04/2012 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/2012/202788s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788_subsys_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202788Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202788s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202788Orig1s023ltr.pdf
12/23/2020 SUPPL-21 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202788Orig1s021ltr.pdf
10/07/2019 SUPPL-20 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202788s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202788Orig1s020ltr.pdf
09/07/2017 SUPPL-18 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202788Orig1s018ltr.pdf
11/09/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/16/2016 SUPPL-16 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202788Orig1s016ltr.pdf
02/12/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/09/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/24/2014 SUPPL-12 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf
12/24/2014 SUPPL-11 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf
11/07/2013 SUPPL-10 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s010ltr.pdf
12/24/2014 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202788Orig1s009,s011,012ltr.pdf
07/31/2013 SUPPL-6 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006ltr.pdf
07/31/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202788Orig1s005,s006ltr.pdf
06/05/2012 SUPPL-3 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf
08/30/2012 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788Orig1s002ltr.pdf
06/05/2012 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202788s001,s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/04/2021 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202788s023lbl.pdf
10/07/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202788s020lbl.pdf
10/07/2019 SUPPL-20 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202788s020lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf
12/16/2016 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202788s016lbl.pdf
12/24/2014 SUPPL-12 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf
12/24/2014 SUPPL-11 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf
12/24/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf
12/24/2014 SUPPL-9 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202788s009s011s012lbl.pdf
07/31/2013 SUPPL-6 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf
07/31/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202788s005s006lbl.pdf
08/30/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s002lbl.pdf
06/05/2012 SUPPL-3 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf
06/05/2012 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s001s003lbl.pdf
01/04/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202788s000lbl.pdf

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