FDA ANDA · ANDA207490
BUPRENORPHINE TRANSDERMAL SYSTEM
buprenorphine
Sponsor: STRIDES PHARMA INTL
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APPLICATION
ANDA207490
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-17
LATEST ACTION
2026-10-13
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription, Discontinued
Products
BUPRENORPHINEPrescription
BUPRENORPHINE 5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEPrescription
BUPRENORPHINE 20MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEPrescription
BUPRENORPHINE 10MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEDiscontinued
BUPRENORPHINE 7.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
BUPRENORPHINEPrescription
BUPRENORPHINE 15MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2026-10-13Labeling · Supplement 7 · standardAP
2026-10-13Labeling · Supplement 11 · standardAP
2026-06-18REMS · Supplement 12AP
2024-10-31REMS · Supplement 6AP
2022-11-22Labeling · Supplement 1 · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →