ANDA 212071

EXELA PHARMA

FDA Drug Application

Application #212071

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 212071

EXELA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.4MG COPPER/ML

0

CUPRIC CHLORIDE

CUPRIC CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-31

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212071
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CUPRIC CHLORIDE","activeIngredients":"CUPRIC CHLORIDE","strength":"EQ 0.4MG COPPER\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-31
        )

)