ANDA 209914

ENCUBE ETHICALS

FDA Drug Application

Application #209914

Application Sponsors

ANDA 209914

ENCUBE ETHICALS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

EQ 1% BASE

0

CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-01-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2021-03-18	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AT

CDER Filings

ENCUBE ETHICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209914
            [companyName] => ENCUBE ETHICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 1% BASE","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-12
        )

)