GLASSHOUSE PHARMS FDA Approval ANDA 209846

ANDA 209846

GLASSHOUSE PHARMS

FDA Drug Application

Application #209846

Application Sponsors

ANDA 209846GLASSHOUSE PHARMS

Marketing Status

Prescription001

Application Products

001SOLUTION;TOPICALEQ 1% BASE0CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2018-02-08STANDARD
LABELING; LabelingSUPPL3AP2020-02-12STANDARD
LABELING; LabelingSUPPL4AP2020-02-12STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null15
SUPPL4Null15

TE Codes

001PrescriptionAT

CDER Filings

GLASSHOUSE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209846
            [companyName] => GLASSHOUSE PHARMS
            [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":"02\/08\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/12\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-02-12
        )

)

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