Application Sponsors
| ANDA 206181 | AJANTA PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 50MG | 0 | VORICONAZOLE | VORICONAZOLE |
| 002 | TABLET;ORAL | 200MG | 0 | VORICONAZOLE | VORICONAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-05-24 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-07-08 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2021-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2021-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2022-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2022-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2022-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2022-11-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 22 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AJANTA PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 206181
[companyName] => AJANTA PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/08\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/08\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-07-08
)
)