ANDA 214688

GLENMARK PHARMS LTD

FDA Drug Application

Application #214688

Application Sponsors

ANDA 214688

GLENMARK PHARMS LTD

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-05-06

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214688
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","activeIngredients":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","strength":"0.064%;0.005%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/06\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-06
        )

)