← FDA DRUG APPROVALS

FDA NDA · NDA205637

BUNAVAIL

Sponsor: BDSI

APPLICATION
NDA205637
TYPE
NDA
ORIGINAL APPROVAL
2014-06-06
LATEST ACTION
2022-12-16
ROUTE
BUCCAL
DOSAGE FORM
FILM
MARKETING STATUS
Discontinued

Products

BUNAVAIL · ReferenceDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 4.2MG BASE, NALOXONE HYDROCHLORIDE EQ 0.7MG BASE · FILM · BUCCAL
BUNAVAIL · ReferenceDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 6.3MG BASE, NALOXONE HYDROCHLORIDE EQ 1MG BASE · FILM · BUCCAL
BUNAVAIL · ReferenceDiscontinued
BUPRENORPHINE HYDROCHLORIDE EQ 2.1MG BASE, NALOXONE HYDROCHLORIDE EQ 0.3MG BASE · FILM · BUCCAL

Approval history

2022-12-16REMS · Supplement 25 — Letter ↗AP
2022-06-17Labeling · Supplement 24 · standard — Letter ↗AP
2022-06-17Labeling · Supplement 23 · standard — Letter ↗AP
2022-05-03REMS · Supplement 22 — Letter ↗AP
2021-03-04Labeling · Supplement 21 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 20 · standard — Letter ↗AP
2018-10-31REMS · Supplement 19 — Letter ↗AP
2018-02-01Labeling · Supplement 16 · standard — Label ↗AP
2018-01-25Labeling · Supplement 1 · standardAP
2017-05-23REMS · Supplement 14 — Letter ↗AP
2017-04-27Efficacy · Supplement 7 · standard — Label ↗AP
2017-04-27Labeling · Supplement 13 · standard — Label ↗AP
2016-12-16Labeling · Supplement 11 · standard — Label ↗AP
2016-07-07REMS · Supplement 9 — Letter ↗AP
2015-10-14Manufacturing (CMC) · Supplement 6 · standardAP
2015-04-24Manufacturing (CMC) · Supplement 3 · standardAP
2015-02-12REMS · Supplement 4 — Letter ↗AP
2014-06-06Type 3 - New Dosage Form · Original · standard — Other ↗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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