APPLICATION
ANDA077154
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-09
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-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 41AP
2025-12-22Labeling · Supplement 38 · standardAP
2025-12-22Labeling · Supplement 40 · standardAP
2024-10-31REMS · Supplement 39AP
2023-12-15Labeling · Supplement 37 · standardAP
2023-12-15Labeling · Supplement 35 · standardAP
2023-12-08Labeling · Supplement 29 · standardAP
2020-05-06Labeling · Supplement 19 · standardAP
2020-05-06Labeling · Supplement 25 · standardAP
2020-05-06Labeling · Supplement 23 · standardAP
2020-05-06Labeling · Supplement 21 · standardAP
2020-05-06Labeling · Supplement 24 · standardAP
2018-09-18REMS · Supplement 20AP
2017-05-26REMS · Supplement 17AP
2016-09-30REMS · Supplement 16AP
2016-04-20REMS · Supplement 12AP
2015-06-26REMS · Supplement 11AP
2015-06-11Manufacturing (CMC) · Supplement 2AP
2014-08-19REMS · Supplement 10AP
2014-06-16Labeling · Supplement 8 · standardAP
2013-04-15REMS · Supplement 6AP
2012-07-09Labeling · Supplement 5AP
2012-07-09REMS · Supplement 3AP
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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