ANDA 213693

ASPEN

FDA Drug Application

Application #213693

Application Sponsors

ANDA 213693

ASPEN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

6GM/30ML (200MG/ML)

0

ACETYLCYSTEINE

ACETYLCYSTEINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-02-03

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

ASPEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213693
            [companyName] => ASPEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETYLCYSTEINE","activeIngredients":"ACETYLCYSTEINE","strength":"6GM\/30ML (200MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-02-03
        )

)