Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL-28 | 3MG;0.03MG | 1 | YASMIN | DROSPIRENONE; ETHINYL ESTRADIOL |
FDA Submissions
| TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 2001-05-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2001-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-11-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2001-12-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2003-05-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-08-08 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2010-04-07 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2012-02-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2013-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2012-04-10 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2015-06-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2014-11-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2014-09-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2016-03-08 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2017-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2022-04-29 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 23 | Null | 15 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 30 | Null | 7 |
TE Codes
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 21098
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)