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FDA NDA · NDA204442

PROBUPHINE

Sponsor: REACX PHARMS

APPLICATION
NDA204442
TYPE
NDA
ORIGINAL APPROVAL
2016-05-26
LATEST ACTION
2025-12-22
ROUTE
IMPLANTATION
DOSAGE FORM
IMPLANT
MARKETING STATUS
Discontinued

Products

PROBUPHINE · ReferenceDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 80MG BASE/IMPLANT · IMPLANT · IMPLANTATION

Approval history

2025-12-22Labeling · Supplement 15 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 14 · standard — Label ↗AP
2023-03-23Labeling · Supplement 13 · standard — Label ↗AP
2022-06-17Labeling · Supplement 12 · standard — Letter ↗AP
2021-03-04Labeling · Supplement 11 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 9 · standard — Letter ↗AP
2018-11-01REMS · Supplement 7 — Letter ↗AP
2018-02-01Labeling · Supplement 6 · standard — Label ↗AP
2017-07-28Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2017-07-28Labeling · Supplement 2 · standard — Label ↗AP
2017-04-19REMS · Supplement 3 — Letter ↗AP
2016-05-26Type 3 - New Dosage Form · Original · priority — REMS ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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