Application Sponsors
| ANDA 210054 | AJANTA PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 500MG | 0 | RANOLAZINE | RANOLAZINE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 1GM | 0 | RANOLAZINE | RANOLAZINE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2019-05-28 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-10-31 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-02-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 8 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AJANTA PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 210054
[companyName] => AJANTA PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RANOLAZINE","activeIngredients":"RANOLAZINE","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"02\/24\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-24
)
)