APPLICATION
ANDA210272
TYPE
ANDA
ORIGINAL APPROVAL
2021-09-23
LATEST ACTION
2026-06-18
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
BUPRENORPHINEPrescription
BUPRENORPHINE 15MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEPrescription
BUPRENORPHINE 7.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEPrescription
BUPRENORPHINE 20MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEPrescription
BUPRENORPHINE 10MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEPrescription
BUPRENORPHINE 5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2026-06-18REMS · Supplement 13AP
2024-10-31REMS · Supplement 8AP
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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