ANDA 214201

GUARDIAN DRUG

FDA Drug Application

Application #214201

Application Sponsors

ANDA 214201

GUARDIAN DRUG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL, RECTAL

66%;10%

0

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

GUARDIAN DRUG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214201
            [companyName] => GUARDIAN DRUG
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM","activeIngredients":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","strength":"66%;10%","dosageForm":"SOLUTION;ORAL, RECTAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-27
        )

)