← FDA DRUG APPROVALS

FDA NDA · NDA019813

DURAGESIC-100

Sponsor: JANSSEN PHARMS

APPLICATION
NDA019813
TYPE
NDA
ORIGINAL APPROVAL
1990-08-07
LATEST ACTION
2021-03-04
ROUTE
TRANSDERMAL
DOSAGE FORM
FILM, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DURAGESIC-100 · ReferenceDiscontinued
FENTANYL 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
DURAGESIC-37 · ReferenceDiscontinued
FENTANYL 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
DURAGESIC-25 · ReferenceDiscontinued
FENTANYL 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
DURAGESIC-75 · ReferenceDiscontinued
FENTANYL 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
DURAGESIC-12 · ReferenceDiscontinued
FENTANYL 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL
DURAGESIC-50 · ReferenceDiscontinued
FENTANYL 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FILM, EXTENDED RELEASE · TRANSDERMAL

Approval history

2021-03-04Labeling · Supplement 81 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 79 · standard — Label ↗AP
2018-09-18REMS · Supplement 75 — Letter ↗AP
2018-09-18Labeling · Supplement 76 · standard — Letter ↗AP
2018-01-24Manufacturing (CMC) · Supplement 73 · standard — Label ↗AP
2018-01-24Efficacy · Supplement 72 · standard — Label ↗AP
2017-05-26REMS · Supplement 74 — Letter ↗AP
2017-02-10Labeling · Supplement 68 · standard — Letter ↗AP
2017-02-02Labeling · Supplement 70 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 69 · standard — Letter ↗AP
2016-09-30REMS · Supplement 71 — Letter ↗AP
2016-04-20REMS · Supplement 67 — Letter ↗AP
2015-06-26REMS · Supplement 66 — Letter ↗AP
2014-08-19REMS · Supplement 65 — Letter ↗AP
2014-06-08Manufacturing (CMC) · Supplement 64 · standardAP
2014-04-16Labeling · Supplement 63 · 901 required — Letter ↗AP
2013-09-23Manufacturing (CMC) · Supplement 60 — Label ↗AP
2013-07-26Manufacturing (CMC) · Supplement 59 · standardAP
2013-04-15REMS · Supplement 56 — Letter ↗AP
2012-12-19Manufacturing (CMC) · Supplement 55 · standardAP
2012-07-09REMS · Supplement 52 — Letter ↗AP
2012-07-09Labeling · Supplement 51 · standard — Letter ↗AP
2009-07-31Manufacturing (CMC) · Supplement 44 — Review ↗AP
2008-02-07Labeling · Supplement 33 · standard — Letter ↗AP
2005-02-04Efficacy · Supplement 39 · unknown — Review ↗AP
2003-05-20Efficacy · Supplement 36 · priority — Review ↗AP
2001-04-11Labeling · Supplement 23 · standard — Letter ↗AP
2001-04-09Labeling · Supplement 30 · standard — Letter ↗AP
2000-11-09Manufacturing (CMC) · Supplement 28 · standardAP
2000-11-09Manufacturing (CMC) · Supplement 29 · standardAP
2000-11-01Labeling · Supplement 26 · standard — Review ↗AP
2000-11-01Labeling · Supplement 25 · standard — Review ↗AP
2000-04-26Manufacturing (CMC) · Supplement 27 · standardAP
1999-12-07Manufacturing (CMC) · Supplement 22 · standardAP
1999-12-02Manufacturing (CMC) · Supplement 24 · standardAP
1997-07-17Labeling · Supplement 18 · standard — Review ↗AP
1997-07-17Labeling · Supplement 20 · standard — Review ↗AP
1997-07-17Labeling · Supplement 19 · standard — Review ↗AP
1997-07-17Labeling · Supplement 21 · standard — Review ↗AP
1997-06-19Manufacturing (CMC) · Supplement 15 · standardAP
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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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