ANDA 209846

GLASSHOUSE PHARMS

FDA Drug Application

Application #209846

Application Sponsors

ANDA 209846

GLASSHOUSE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

EQ 1% BASE

0

CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-02-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-02-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-02-12	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AT

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
        )

)