Application Sponsors
| ANDA 090612 | NATCO PHARMA LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG | 0 | CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE |
FDA Submissions
| ORIG | 1 | AP | 2011-01-21 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2022-03-17 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2022-03-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-05-03 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
TE Codes
CDER Filings
NATCO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90612
[companyName] => NATCO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CHLOROQUINE PHOSPHATE","activeIngredients":"CHLOROQUINE PHOSPHATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLOROQUINE PHOSPHATE","submission":"CHLOROQUINE PHOSPHATE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)