ANDA 213658

MICRO LABS

FDA Drug Application

Application #213658

Application Sponsors

ANDA 213658

MICRO LABS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

10MG/ML

0

CROMOLYN SODIUM

CROMOLYN SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AN

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213658
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CROMOLYN SODIUM","activeIngredients":"CROMOLYN SODIUM","strength":"10MG\/ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-29
        )

)