APPLICATION
ANDA202097
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-04
LATEST ACTION
2026-06-18
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
FENTANYL-100Prescription
FENTANYL 100MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-50Prescription
FENTANYL 50MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-12Prescription
FENTANYL 12.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-75Prescription
FENTANYL 75MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-25Prescription
FENTANYL 25MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2026-06-18REMS · Supplement 29AP
2025-12-22Labeling · Supplement 26 · standardAP
2024-10-31REMS · Supplement 20AP
2023-12-15Labeling · Supplement 17 · standardAP
2023-12-11Labeling · Supplement 10 · standardAP
2023-12-11Labeling · Supplement 6 · standardAP
2023-12-11Labeling · Supplement 2 · standardAP
2023-12-11Labeling · Supplement 9 · standardAP
2018-09-18REMS · Supplement 4AP
2017-05-26REMS · 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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