Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
Application Products
| 001 | FILM, EXTENDED RELEASE;TRANSDERMAL | 100MCG/HR | 1 | DURAGESIC-100 | FENTANYL |
| 002 | FILM, EXTENDED RELEASE;TRANSDERMAL | 75MCG/HR | 1 | DURAGESIC-75 | FENTANYL |
| 003 | FILM, EXTENDED RELEASE;TRANSDERMAL | 50MCG/HR | 1 | DURAGESIC-50 | FENTANYL |
| 004 | FILM, EXTENDED RELEASE;TRANSDERMAL | 25MCG/HR | 1 | DURAGESIC-25 | FENTANYL |
| 005 | FILM, EXTENDED RELEASE;TRANSDERMAL | 12.5MCG/HR | 1 | DURAGESIC-12 | FENTANYL |
| 006 | FILM, EXTENDED RELEASE;TRANSDERMAL | 37.5MCG/HR | 1 | DURAGESIC-37 | FENTANYL |
FDA Submissions
| TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage Form | ORIG | 1 | AP | 1990-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1990-10-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1991-02-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1991-07-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1993-07-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1993-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1993-10-25 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 1994-01-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1994-03-29 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 1994-11-07 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1997-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1997-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 1997-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1997-07-17 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1999-12-07 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2001-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1999-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2000-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2000-11-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2000-04-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2000-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2000-11-09 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2001-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2008-02-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2003-05-20 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 39 | AP | 2005-02-04 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 2009-07-31 | N/A |
| LABELING; Labeling | SUPPL | 51 | AP | 2012-07-09 | STANDARD |
| REMS; REMS | SUPPL | 52 | AP | 2012-07-09 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2012-12-19 | STANDARD |
| REMS; REMS | SUPPL | 56 | AP | 2013-04-15 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 59 | AP | 2013-07-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 60 | AP | 2013-09-23 | N/A |
| LABELING; Labeling | SUPPL | 63 | AP | 2014-04-16 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 64 | AP | 2014-06-08 | STANDARD |
| REMS; REMS | SUPPL | 65 | AP | 2014-08-19 | N/A |
| REMS; REMS | SUPPL | 66 | AP | 2015-06-26 | N/A |
| REMS; REMS | SUPPL | 67 | AP | 2016-04-20 | N/A |
| LABELING; Labeling | SUPPL | 68 | AP | 2017-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2017-02-02 | STANDARD |
| REMS; REMS | SUPPL | 71 | AP | 2016-09-30 | N/A |
| EFFICACY; Efficacy | SUPPL | 72 | AP | 2018-01-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 73 | AP | 2018-01-24 | STANDARD |
| REMS; REMS | SUPPL | 74 | AP | 2017-05-26 | N/A |
| REMS; REMS | SUPPL | 75 | AP | 2018-09-18 | N/A |
| LABELING; Labeling | SUPPL | 76 | AP | 2018-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 79 | AP | 2019-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 81 | AP | 2021-03-04 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 52 | Null | 6 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 15 |
| SUPPL | 59 | Null | 0 |
| SUPPL | 60 | Null | 15 |
| SUPPL | 63 | Null | 7 |
| SUPPL | 64 | Null | 0 |
| SUPPL | 65 | Null | 6 |
| SUPPL | 66 | Null | 7 |
| SUPPL | 67 | Null | 7 |
| SUPPL | 68 | Null | 15 |
| SUPPL | 69 | Null | 6 |
| SUPPL | 70 | Null | 6 |
| SUPPL | 71 | Null | 6 |
| SUPPL | 72 | Null | 7 |
| SUPPL | 74 | Null | 7 |
| SUPPL | 75 | Null | 7 |
| SUPPL | 76 | Null | 15 |
| SUPPL | 79 | Null | 7 |
| SUPPL | 81 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
| 006 | Prescription | AB |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 19813
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/019813s081lbl.pdf#page=52"]
[products] => [{"drugName":"DURAGESIC-100","activeIngredients":"FENTANYL","strength":"100MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURAGESIC-12","activeIngredients":"FENTANYL","strength":"12.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURAGESIC-25","activeIngredients":"FENTANYL","strength":"25MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURAGESIC-37","activeIngredients":"FENTANYL","strength":"37.5MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURAGESIC-50","activeIngredients":"FENTANYL","strength":"50MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURAGESIC-75","activeIngredients":"FENTANYL","strength":"75MCG\/HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/04\/2021","submission":"SUPPL-81","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/019813s081lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-79","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019813s079lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"SUPPL-79","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019813s079lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019813s075s076lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2018","submission":"SUPPL-75","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019813s075s076lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2018","submission":"SUPPL-73","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019813s072s073lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2018","submission":"SUPPL-72","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019813s072s073lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-69","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019813s069lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019813s069lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019813s063lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2013","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019813s060lblcorrection.pdf\"}]","notes":""},{"actionDate":"07\/09\/2012","submission":"SUPPL-52","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019813s052lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"SUPPL-44","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019813s044lblnew.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019813s044lblnew.pdf\"}]","notes":""},{"actionDate":"02\/07\/2008","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019813s033lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2005","submission":"SUPPL-39","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/19813s039lbl.pdf\"}]","notes":""},{"actionDate":"05\/20\/2003","submission":"SUPPL-36","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19813se1-036_duragesic_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DURAGESIC-100","submission":"FENTANYL","actionType":"100MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURAGESIC-12","submission":"FENTANYL","actionType":"12.5MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURAGESIC-25","submission":"FENTANYL","actionType":"25MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURAGESIC-37","submission":"FENTANYL","actionType":"37.5MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURAGESIC-50","submission":"FENTANYL","actionType":"50MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURAGESIC-75","submission":"FENTANYL","actionType":"75MCG\/HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-03-04
)
)