ANDA 210508

LUKARE MEDICAL LLC

FDA Drug Application

Application #210508

Application Sponsors

ANDA 210508

LUKARE MEDICAL LLC

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

1GM/SCOOPFUL

0

BETAINE

BETAINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-28

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

LUKARE MEDICAL LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210508
            [companyName] => LUKARE MEDICAL LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAINE","activeIngredients":"BETAINE","strength":"1GM\/SCOOPFUL","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETAINE","submission":"BETAINE","actionType":"1GM\/SCOOPFUL","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)