ANDA 213073

NIVAGEN PHARMS INC

FDA Drug Application

Application #213073

Application Sponsors

ANDA 213073

NIVAGEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

7.25%

0

CYSTEINE HYDROCHLORIDE

CYSTEINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-26

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

NIVAGEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213073
            [companyName] => NIVAGEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYSTEINE HYDROCHLORIDE","activeIngredients":"CYSTEINE HYDROCHLORIDE","strength":"7.25%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/26\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-26
        )

)