ANDA 212197

QUAGEN

FDA Drug Application

Application #212197

Application Sponsors

ANDA 212197

QUAGEN

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

EQ 2MG BASE/5ML

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

QUAGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212197
            [companyName] => QUAGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 2MG BASE\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-06
        )

)