Application Sponsors
| ANDA 202742 | MYLAN LABS LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 0.02MG;1MG | 0 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-10-30 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-04-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 17 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
TE Codes
CDER Filings
MYLAN LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202742
[companyName] => MYLAN LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE","activeIngredients":"ETHINYL ESTRADIOL; NORETHINDRONE ACETATE","strength":"0.02MG;1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/30\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/08\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Proprietary Name Change, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-11-08
)
)