Application Sponsors
ANDA 205663 | UNIQUE PHARM LABS | |
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 450MG | 0 | LITHIUM CARBONATE | LITHIUM CARBONATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-06-05 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2018-12-20 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2020-02-28 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2022-10-13 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 7 |
SUPPL | 5 | Null | 15 |
SUPPL | 9 | Null | 7 |
TE Codes
CDER Filings
UNIQUE PHARM LABS
cder:Array
(
[0] => Array
(
[ApplNo] => 205663
[companyName] => UNIQUE PHARM LABS
[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":"06\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/28\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/20\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/07\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-28
)
)