Application Sponsors
| ANDA 090978 | NATCO PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET, CHEWABLE;ORAL | EQ 500MG BASE | 0 | LANTHANUM CARBONATE | LANTHANUM CARBONATE |
| 002 | TABLET, CHEWABLE;ORAL | EQ 750MG BASE | 0 | LANTHANUM CARBONATE | LANTHANUM CARBONATE |
| 003 | TABLET, CHEWABLE;ORAL | EQ 1GM BASE | 0 | LANTHANUM CARBONATE | LANTHANUM CARBONATE |
FDA Submissions
| ORIG | 1 | AP | 2017-08-11 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2022-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-07-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 17 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
NATCO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90978
[companyName] => NATCO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LANTHANUM CARBONATE","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 500MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANTHANUM CARBONATE","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 750MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LANTHANUM CARBONATE","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 1GM BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"LANTHANUM CARBONATE","submission":"LANTHANUM CARBONATE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LANTHANUM CARBONATE","submission":"LANTHANUM CARBONATE","actionType":"EQ 750MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LANTHANUM CARBONATE","submission":"LANTHANUM CARBONATE","actionType":"EQ 1GM BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)