Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 0.25MG;0.5MG | 1 | ANGELIQ | DROSPIRENONE; ESTRADIOL |
| 002 | TABLET;ORAL | 0.5MG;1MG | 1 | ANGELIQ | DROSPIRENONE; ESTRADIOL |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2005-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2012-02-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2012-02-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2015-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-11-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 6 |
CDER Filings
BAYER HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 21355
[companyName] => BAYER HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"ANGELIQ","activeIngredients":"DROSPIRENONE; ESTRADIOL","strength":"0.25MG;0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ANGELIQ","activeIngredients":"DROSPIRENONE; ESTRADIOL","strength":"0.5MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/01\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021355s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021355s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/29\/2012","submission":"SUPPL-3","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021355s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/29\/2012","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021355s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021355lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ANGELIQ","submission":"DROSPIRENONE; ESTRADIOL","actionType":"0.25MG;0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ANGELIQ","submission":"DROSPIRENONE; ESTRADIOL","actionType":"0.5MG;1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-11-01
)
)