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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204442
Company: REACX PHARMS

Medication Guide

REMS

Products on NDA 204442

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROBUPHINE	BUPRENORPHINE HYDROCHLORIDE	EQ 80MG BASE/IMPLANT	IMPLANT;IMPLANTATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204442

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204442s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204442Orig1s015ltr.pdf
12/15/2023	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204442s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204442Orig1s014ltr.pdf
03/23/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204442s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204442Orig1s013ltr.pdf
06/17/2022	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204442s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204442Orig1s012ltr.pdf
03/04/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204442s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204442Orig1s011ltr.pdf
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

Labels for NDA 204442

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204442s015lbl.pdf
12/22/2025	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204442s015lbl.pdf
12/15/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204442s014lbl.pdf
12/15/2023	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204442s014lbl.pdf
03/23/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204442s013lbl.pdf
06/17/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204442s012lbl.pdf
03/04/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204442s011lbl.pdf
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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