Application Sponsors
| ANDA 206741 | ALEMBIC PHARMS LTD | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 100MG | 0 | ITRACONAZOLE | ITRACONAZOLE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2016-12-13 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2019-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2019-10-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 7 |
TE Codes
CDER Filings
ALEMBIC PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 206741
[companyName] => ALEMBIC PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ITRACONAZOLE","activeIngredients":"ITRACONAZOLE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/13\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/04\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-04
)
)