Application Sponsors
| ANDA 202219 | MYLAN PHARMS INC | |
Marketing Status
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 450MG | 0 | LITHIUM CARBONATE | LITHIUM CARBONATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2012-08-08 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-12-06 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2020-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-10-13 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 9 | Null | 15 |
TE Codes
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202219
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"450MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/08\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/05\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/20\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/06\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-05
)
)