Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204442
Company: TITAN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROBUPHINE BUPRENORPHINE HYDROCHLORIDE EQ 80MG BASE/IMPLANT IMPLANT;IMPLANTATION 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
05/26/2016 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204442Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204442Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204442Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204442s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204442Orig1s009ltr.pdf
11/01/2018 SUPPL-7 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204442Orig1s007Ltr.pdf
02/01/2018 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204442Orig1s006ltr.pdf
07/28/2017 SUPPL-4 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204442s002s004lbl.pdf
04/19/2017 SUPPL-3 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204442Orig1s003ltr.pdf
07/28/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204442s002s004lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204442s009lbl.pdf
02/01/2018 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf
07/28/2017 SUPPL-4 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204442s002s004lbl.pdf
07/28/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204442s002s004lbl.pdf
05/26/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204442Orig1s000lbl.pdf

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