Documents
Application Sponsors
| NDA 021529 | ORGANON USA INC | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | IMPLANT;IMPLANTATION | 68MG/IMPLANT | 0 | IMPLANON | ETONOGESTREL |
| 002 | IMPLANT;IMPLANTATION | 68MG/IMPLANT | 1 | NEXPLANON | ETONOGESTREL |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2006-07-17 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2009-02-19 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2012-02-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2011-05-13 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2014-07-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2013-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2013-09-27 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2015-08-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2015-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2016-03-14 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2017-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2019-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2020-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2020-09-24 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 31 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 15 | Null | 15 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 19 | Null | 15 |
| SUPPL | 20 | Null | 6 |
CDER Filings
ORGANON USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21529
[companyName] => ORGANON USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"IMPLANON","activeIngredients":"ETONOGESTREL","strength":"68MG\/IMPLANT","dosageForm":"IMPLANT;IMPLANTATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEXPLANON","activeIngredients":"ETONOGESTREL","strength":"68MG\/IMPLANT","dosageForm":"IMPLANT;IMPLANTATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/24\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021529s019s020lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021529s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021529s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/14\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021529s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021529s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2014","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021529s008lblrev.pdf\"}]","notes":""},{"actionDate":"09\/27\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021529s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2012","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021529s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2011","submission":"SUPPL-7","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021529s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2009","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021529s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021529lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"IMPLANON","submission":"ETONOGESTREL","actionType":"68MG\/IMPLANT","submissionClassification":"IMPLANT;IMPLANTATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEXPLANON","submission":"ETONOGESTREL","actionType":"68MG\/IMPLANT","submissionClassification":"IMPLANT;IMPLANTATION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-09-24
)
)