APPLICATION
ANDA076709
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-20
LATEST ACTION
2018-09-18
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
FENTANYL-75Discontinued
FENTANYL 75MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-25Discontinued
FENTANYL 25MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-100Discontinued
FENTANYL 100MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
FENTANYL-50Discontinued
FENTANYL 50MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
Approval history
2018-09-18REMS · Supplement 31AP
2017-05-26REMS · Supplement 28AP
2016-09-30REMS · Supplement 27AP
2016-04-20REMS · Supplement 26AP
2015-06-26REMS · Supplement 25AP
2014-09-05Manufacturing (CMC) · Supplement 21 · unknownAP
2014-08-19REMS · Supplement 24AP
2014-06-20Labeling · Supplement 22 · standardAP
2013-04-15REMS · Supplement 18AP
2012-07-27Labeling · Supplement 15AP
2012-07-09REMS · Supplement 12AP
2011-12-02Labeling · Supplement 13AP
2007-12-17Labeling · 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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