Application Sponsors
| ANDA 204445 | ALEMBIC PHARMS LTD | |
Marketing Status
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 300MG | 0 | LITHIUM CARBONATE | LITHIUM CARBONATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-06-08 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-02-14 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2020-02-14 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-07-13 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 8 | Null | 15 |
TE Codes
CDER Filings
ALEMBIC PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204445
[companyName] => ALEMBIC PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"300MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/13\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/14\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/14\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/14\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-13
)
)