Documents
Application Sponsors
| ANDA 207531 | EPIC PHARMA LLC | |
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 | 2018-04-09 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2019-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2022-07-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 31 |
| SUPPL | 8 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
EPIC PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 207531
[companyName] => EPIC PHARMA LLC
[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":"04\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207531Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"07\/25\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-07-25
)
)