ANDA 212438

ENCUBE

FDA Drug Application

Application #212438

Application Sponsors

ANDA 212438

ENCUBE

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

EQ 1% BASE

0

CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-11

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ENCUBE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212438
            [companyName] => ENCUBE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 1% BASE","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-11
        )

)