Documents
Application Sponsors
| NDA 020870 | NOVEN PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.05MG/24HR;0.14MG/24HR | 1 | COMBIPATCH | ESTRADIOL; NORETHINDRONE ACETATE |
| 002 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.05MG/24HR;0.25MG/24HR | 1 | COMBIPATCH | ESTRADIOL; NORETHINDRONE ACETATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1998-08-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-02-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2000-04-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-05-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-03-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-04-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-02-12 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2004-06-18 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2005-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2005-11-16 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2013-09-19 | UNKNOWN |
| LABELING; Labeling | SUPPL | 19 | AP | 2015-05-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2015-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2017-11-01 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 23 | Null | 7 |
CDER Filings
NOVEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20870
[companyName] => NOVEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"COMBIPATCH","activeIngredients":"ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.05MG\/24HR;0.14MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"COMBIPATCH","activeIngredients":"ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.05MG\/24HR;0.25MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/01\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020870s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020870s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2013","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020870s017lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2005","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020870s015lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2005","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/20870s013lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2004","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20870slr010_CombiPatch_lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20870lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"COMBIPATCH","submission":"ESTRADIOL; NORETHINDRONE ACETATE","actionType":"0.05MG\/24HR;0.14MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"COMBIPATCH","submission":"ESTRADIOL; NORETHINDRONE ACETATE","actionType":"0.05MG\/24HR;0.25MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-11-01
)
)