Application Sponsors
| ANDA 203503 | GLENMARK PHARMS 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 | 2015-09-02 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-06-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2022-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2022-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2022-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-11-29 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-11-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
GLENMARK PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203503
[companyName] => GLENMARK PHARMS 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":"09\/02\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/28\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/28\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/28\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-06-28
)
)