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FDA ANDA · ANDA209655

FENTANYL-100

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA209655
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-24
LATEST ACTION
2026-06-18
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

FENTANYL-100Discontinued
FENTANYL 100MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-75Discontinued
FENTANYL 75MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-50Discontinued
FENTANYL 50MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-25Discontinued
FENTANYL 25MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-87Discontinued
FENTANYL 87.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-62Discontinued
FENTANYL 62.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-37Discontinued
FENTANYL 37.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-12Discontinued
FENTANYL 12.5MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2026-06-18REMS · Supplement 7AP
2025-12-22Labeling · Supplement 5 · standardAP
2024-10-31REMS · Supplement 3AP
2023-12-15Labeling · Supplement 1 · standardAP
2023-12-15Labeling · Supplement 2 · standardAP
2023-01-24UNKNOWN · Original · standard — REMS ↗AP
VIEW ON DRUGS@FDA ↗

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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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