← FDA DRUG APPROVALS

FDA NDA · NDA021306

BUTRANS

buprenorphine

Sponsor: KNOA PHARMA

APPLICATION
NDA021306
TYPE
NDA
ORIGINAL APPROVAL
2010-06-30
LATEST ACTION
2026-06-18
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

BUTRANS · ReferencePrescription
BUPRENORPHINE 15MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUTRANS · ReferencePrescription
BUPRENORPHINE 10MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUTRANS · ReferencePrescription
BUPRENORPHINE 7.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUTRANS · ReferencePrescription
BUPRENORPHINE 20MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUTRANS · ReferencePrescription
BUPRENORPHINE 5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2026-06-18REMS · Supplement 45 — Letter ↗AP
2025-12-22Labeling · Supplement 44 · standard — Letter ↗AP
2024-10-31REMS · Supplement 42 — Letter ↗AP
2023-12-15Labeling · Supplement 41 · standard — Label ↗AP
2022-06-17Labeling · Supplement 39 · standard — Letter ↗AP
2021-03-04Labeling · Supplement 37 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 35 · standard — Label ↗AP
2018-09-18Labeling · Supplement 34 · standard — Letter ↗AP
2018-09-18REMS · Supplement 32 — Letter ↗AP
2017-10-13Efficacy · Supplement 27 · standard — Label ↗AP
2017-08-14REMS · Supplement 31 — Letter ↗AP
2017-05-26REMS · Supplement 30 — Label ↗AP
2016-12-16Labeling · Supplement 24 · standard — Letter ↗AP
2016-09-30REMS · Supplement 26 — Letter ↗AP
2016-04-20REMS · Supplement 23 — Letter ↗AP
2015-06-26REMS · Supplement 22 — Letter ↗AP
2014-08-19REMS · Supplement 20 — Letter ↗AP
2014-06-30Manufacturing (CMC) · Supplement 19 · standard — Letter ↗AP
2014-06-30Labeling · Supplement 15 · standard — Label ↗AP
2014-04-16Labeling · Supplement 18 · 901 required — Letter ↗AP
2013-07-25Manufacturing (CMC) · Supplement 16 · standard — Label ↗AP
2013-04-15REMS · Supplement 12 — Letter ↗AP
2013-03-08Manufacturing (CMC) · Supplement 13 · standardAP
2012-07-09Labeling · Supplement 8 · standard — Letter ↗AP
2011-07-01Labeling · Supplement 3 · standard — Label ↗AP
2011-07-01Labeling · Supplement 1 · standard — Letter ↗AP
2010-06-30Type 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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