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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209819
Company: INDIVIOR INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUBLOCADE BUPRENORPHINE 100MG/0.5ML (100MG/0.5ML) SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS Prescription None Yes No
SUBLOCADE BUPRENORPHINE 300MG/1.5ML (200MG/ML) SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 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
11/30/2017 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209819s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209819Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209819Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/209819Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/2022 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209819Orig1s020ltr.pdf
09/22/2021 SUPPL-19 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s019ltr.pdf
06/17/2021 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s018ltr.pdf
03/04/2021 SUPPL-17 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s017s018lbl.pdf
06/15/2020 SUPPL-16 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209819Orig1s016ltr.pdf
05/11/2021 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s015ltr.pdf
02/04/2020 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209819s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209819Orig1s012ltr.pdf
08/23/2022 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209819Orig1s010ltr.pdf
10/07/2019 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209819s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209819Orig1s009ltr.pdf
03/05/2018 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209819Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/23/2022 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s010lbl.pdf
06/17/2022 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s020lbl.pdf
06/17/2021 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s018lbl.pdf
05/11/2021 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s015lbl.pdf
03/04/2021 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s017s018lbl.pdf
02/04/2020 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209819s012lbl.pdf
10/07/2019 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209819s009lbl.pdf
03/05/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf
11/30/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209819s000lbl.pdf
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