APPLICATION
ANDA210162
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-03
LATEST ACTION
2026-06-18
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
BUPRENORPHINEDiscontinued
BUPRENORPHINE 15MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEDiscontinued
BUPRENORPHINE 7.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEDiscontinued
BUPRENORPHINE 20MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEDiscontinued
BUPRENORPHINE 10MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEDiscontinued
BUPRENORPHINE 5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2026-06-18REMS · Supplement 5AP
2025-03-14Labeling · Supplement 3 · standardAP
2025-03-14Labeling · Supplement 1 · standardAP
2024-10-31REMS · Supplement 2AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.