Application Sponsors
| ANDA 203328 | AJANTA PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | 0 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
| 002 | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | 0 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-07-31 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-10-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AJANTA PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203328
[companyName] => AJANTA PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/31\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/08\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-08
)
)