Application Sponsors
| ANDA 209201 | AUROBINDO PHARMA LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | FOR SUSPENSION;ORAL | EQ 100MG BASE/5ML | 0 | AZITHROMYCIN | AZITHROMYCIN |
| 002 | FOR SUSPENSION;ORAL | EQ 200MG BASE/5ML | 0 | AZITHROMYCIN | AZITHROMYCIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2018-10-09 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2020-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2020-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2022-01-12 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209201
[companyName] => AUROBINDO PHARMA LTD
[docInserts] => ["",""]
[products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 100MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 200MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"01\/23\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-01-23
)
)