Application Sponsors
ANDA 209999 | BIONPHARMA INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 600MG BASE | 0 | AZITHROMYCIN | AZITHROMYCIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-12-26 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2021-11-22 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
BIONPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209999
[companyName] => BIONPHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-01
)
)