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FDA NDA · NDA020732

SUBUTEX

Sponsor: INDIVIOR

APPLICATION
NDA020732
TYPE
NDA
ORIGINAL APPROVAL
2002-10-08
LATEST ACTION
2022-06-17
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SUBUTEX · ReferenceDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
SUBUTEX · ReferenceDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL

Approval history

2022-06-17Labeling · Supplement 28 · standard — Letter ↗AP
2022-06-17Labeling · Supplement 27 · standard — Letter ↗AP
2022-05-03REMS · Supplement 26 — Letter ↗AP
2021-11-19REMS · Supplement 25 — Letter ↗AP
2021-03-04Labeling · Supplement 24 · standard — Letter ↗AP
2020-03-02REMS · Supplement 23 — Letter ↗AP
2019-10-31Labeling · Supplement 20 · standard — Label ↗AP
2019-10-07Labeling · Supplement 22 · standard — Letter ↗AP
2018-10-26REMS · Supplement 21 — Letter ↗AP
2018-06-11REMS · Supplement 19 — Letter ↗AP
2018-02-01Labeling · Supplement 18 · standard — Label ↗AP
2017-09-19REMS · Supplement 17 — Letter ↗AP
2017-09-07Labeling · Supplement 16 · standard — Label ↗AP
2016-12-16Labeling · Supplement 14 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 15 · standard — Letter ↗AP
2016-07-07REMS · Supplement 13 — Letter ↗AP
2015-09-22REMS · Supplement 12 — Letter ↗AP
2014-12-11Labeling · Supplement 10 · standard — Label ↗AP
2013-08-08Manufacturing (CMC) · Supplement 9 · standardAP
2011-12-22REMS · Supplement 6 — Letter ↗AP
2011-12-22Labeling · Supplement 7 · unknown — Label ↗AP
2006-10-04Labeling · Supplement 2 · standard — Letter ↗AP
2002-10-08Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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