Application Sponsors
| ANDA 090702 | HETERO LABS LTD III | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | CAPSULE;ORAL | 150MG | 0 | LITHIUM CARBONATE | LITHIUM CARBONATE |
| 002 | CAPSULE;ORAL | 300MG | 0 | LITHIUM CARBONATE | LITHIUM CARBONATE |
| 003 | CAPSULE;ORAL | 600MG | 0 | LITHIUM CARBONATE | LITHIUM CARBONATE |
FDA Submissions
| ORIG | 1 | AP | 2009-09-25 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2012-03-06 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-05-03 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-10-01 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-10-01 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 8 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 10 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
HETERO LABS LTD III
cder:Array
(
[0] => Array
(
[ApplNo] => 90702
[companyName] => HETERO LABS LTD III
[docInserts] => ["",""]
[products] => [{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LITHIUM CARBONATE","activeIngredients":"LITHIUM CARBONATE","strength":"600MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LITHIUM CARBONATE","submission":"LITHIUM CARBONATE","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LITHIUM CARBONATE","submission":"LITHIUM CARBONATE","actionType":"300MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LITHIUM CARBONATE","submission":"LITHIUM CARBONATE","actionType":"600MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)