APPLICATION
ANDA077775
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-16
LATEST ACTION
2016-04-20
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
FENTANYL-50Discontinued
FENTANYL 50MCG/HR · FILM, EXTENDED RELEASE · TRANSDERMAL
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
Approval history
2016-04-20REMS · Supplement 20AP
2015-06-26REMS · Supplement 19AP
2014-08-19REMS · Supplement 18AP
2014-07-03Labeling · Supplement 16 · standardAP
2014-07-03Labeling · Supplement 12 · standardAP
2013-04-15REMS · Supplement 11AP
2012-07-09REMS · Supplement 8AP
2011-02-17Labeling · Supplement 6AP
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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