Application Sponsors
| ANDA 203624 | MYLAN INSTITUTIONAL | |
Marketing Status
Application Products
| 001 | INJECTABLE;INTRAVENOUS | 6GM/30ML (200MG/ML) | 0 | ACETYLCYSTEINE | ACETYLCYSTEINE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-06-19 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-09-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 203624
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"ACETYLCYSTEINE","activeIngredients":"ACETYLCYSTEINE","strength":"6GM\/30ML (200MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/19\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/21\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/21\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-09-04
)
)