Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | EQ 600MG BASE | 0 | AZITHROMYCIN | AZITHROMYCIN |
FDA Submissions
| ORIG | 1 | AP | 2005-11-14 | |
LABELING; Labeling | SUPPL | 13 | AP | 2010-07-30 | |
LABELING; Labeling | SUPPL | 15 | AP | 2016-11-08 | STANDARD |
LABELING; Labeling | SUPPL | 19 | AP | 2020-01-08 | STANDARD |
LABELING; Labeling | SUPPL | 20 | AP | 2020-01-08 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 2020-01-08 | STANDARD |
LABELING; Labeling | SUPPL | 22 | AP | 2020-01-08 | STANDARD |
LABELING; Labeling | SUPPL | 24 | AP | 2021-11-22 | STANDARD |
Submissions Property Types
SUPPL | 15 | Null | 15 |
SUPPL | 19 | Null | 7 |
SUPPL | 20 | Null | 7 |
SUPPL | 21 | Null | 15 |
SUPPL | 22 | Null | 15 |
SUPPL | 24 | Null | 15 |
TE Codes
CDER Filings
PLIVA
cder:Array
(
[0] => Array
(
[ApplNo] => 65218
[companyName] => PLIVA
[docInserts] => ["",""]
[products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 600MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)