ANDA 214082

ETON

FDA Drug Application

Application #214082

Documents

• Letter: 2022-08-26

Application Sponsors

ANDA 214082

ETON

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

500MG/10ML (50MG/ML)

0

CYSTEINE HYDROCHLORIDE

CYSTEINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-08

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

ETON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214082
            [companyName] => ETON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYSTEINE HYDROCHLORIDE","activeIngredients":"CYSTEINE HYDROCHLORIDE","strength":"500MG\/10ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-08
        )

)