ANDA 209045

SUNSHINE LAKE

FDA Drug Application

Application #209045

Application Sponsors

ANDA 209045

SUNSHINE LAKE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 250MG BASE

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2020-01-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2020-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2022-10-11	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	7	Null	7
SUPPL	12	Null	7

TE Codes

001

Prescription

AB

CDER Filings

SUNSHINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209045
            [companyName] => SUNSHINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/01\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/21\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-01
        )

)