APPLICATION
ANDA077449
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-20
LATEST ACTION
2026-06-18
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
FENTANYL-75Prescription
FENTANYL 75MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-25Prescription
FENTANYL 25MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-87Prescription
FENTANYL 87.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-37Prescription
FENTANYL 37.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-100Prescription
FENTANYL 100MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-50Prescription
FENTANYL 50MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-62Prescription
FENTANYL 62.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-12Prescription
FENTANYL 12.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2026-06-18REMS · Supplement 45AP
2025-12-22Labeling · Supplement 44 · standardAP
2025-12-22Labeling · Supplement 42 · standardAP
2024-10-31REMS · Supplement 41AP
2023-12-15Labeling · Supplement 40 · standardAP
2023-12-15Labeling · Supplement 39 · standardAP
2023-12-13Labeling · Supplement 28 · standardAP
2023-12-13Labeling · Supplement 35 · standardAP
2023-12-13Labeling · Supplement 27 · standardAP
2023-12-13Labeling · Supplement 31 · standardAP
2018-09-18REMS · Supplement 26AP
2017-08-10Labeling · Supplement 22 · standardAP
2017-08-10Manufacturing (CMC) · Supplement 25 · unknownAP
2017-05-26REMS · Supplement 24AP
2016-09-30REMS · Supplement 20AP
2016-08-22Manufacturing (CMC) · Supplement 19 · unknownAP
2016-04-20REMS · Supplement 18AP
2015-09-11Supplement 16AP
2015-06-26REMS · Supplement 15AP
2014-08-19REMS · Supplement 11AP
2014-07-23Labeling · Supplement 10 · standardAP
2013-04-19REMS · Supplement 5AP
2013-03-07Labeling · Supplement 4 · standardAP
2013-02-14REMS · Supplement 3AP
2009-03-02Labeling · Supplement 1AP
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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