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FDA NDA · NDA018401

BUPRENEX

Sponsor: INDIVIOR

APPLICATION
NDA018401
TYPE
NDA
ORIGINAL APPROVAL
1981-12-29
LATEST ACTION
2023-12-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

BUPRENEX · ReferenceDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2023-12-15Labeling · Supplement 27 · standard — Label ↗AP
2022-06-17Labeling · Supplement 26 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 25 · standard — Label ↗AP
2016-12-16Labeling · Supplement 22 · standard — Letter ↗AP
2015-05-11Manufacturing (CMC) · Supplement 20 · standardAP
2014-02-06Manufacturing (CMC) · Supplement 18 · standardAP
2013-08-08Manufacturing (CMC) · Supplement 19 · standardAP
2013-01-04Manufacturing (CMC) · Supplement 17 · standardAP
2003-06-10Labeling · Supplement 15 · standard — Review ↗AP
2002-02-11Labeling · Supplement 14 · standard — Letter ↗AP
1995-11-29Manufacturing (CMC) · Supplement 13 · standardAP
1995-02-13Manufacturing (CMC) · Supplement 12 · standardAP
1994-04-29Manufacturing (CMC) · Supplement 10 · standardAP
1993-06-25Labeling · Supplement 11 · standardAP
1989-12-05Manufacturing (CMC) · Supplement 8 · standardAP
1989-03-09Manufacturing (CMC) · Supplement 6 · standardAP
1987-11-19Labeling · Supplement 5AP
1987-02-13Labeling · Supplement 4AP
1985-06-28Labeling · Supplement 1AP
1985-05-17Manufacturing (CMC) · Supplement 3 · standardAP
1982-10-19Manufacturing (CMC) · Supplement 2 · standardAP
1981-12-29Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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