Documents
Application Sponsors
| NDA 020907 | AMNEAL PHARMS LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 1MG;0.5MG | 1 | ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE |
| 002 | TABLET;ORAL | 0.5MG;0.1MG | 1 | ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1998-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2000-02-10 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2000-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-11-14 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2005-06-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-09-13 | STANDARD |
| S; Supplement | SUPPL | 7 | AP | 2004-07-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2006-12-28 | UNKNOWN |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-12-28 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2013-10-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2015-01-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2016-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2017-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2021-08-10 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2021-08-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2020-04-06 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 22 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AMNEAL
cder:Array
(
[0] => Array
(
[ApplNo] => 20907
[companyName] => AMNEAL
[docInserts] => ["",""]
[products] => [{"drugName":"ACTIVELLA","activeIngredients":"ESTRADIOL; NORETHINDRONE ACETATE","strength":"1MG;0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ACTIVELLA","activeIngredients":"ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.5MG;0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"04\/06\/2020","submission":"SUPPL-25","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020907s025lbl.pdf\"}]","notes":""},{"actionDate":"11\/01\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020907s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2013","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020907s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2006","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020907s009s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/28\/2006","submission":"SUPPL-9","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020907s009s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2005","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020907s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20907lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ACTIVELLA","submission":"ESTRADIOL; NORETHINDRONE ACETATE","actionType":"1MG;0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ACTIVELLA","submission":"ESTRADIOL; NORETHINDRONE ACETATE","actionType":"0.5MG;0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-04-06
)
)