ANDA 212007

EXELA PHARMA

FDA Drug Application

Application #212007

Documents

• Letter: 2021-06-15

Application Sponsors

ANDA 212007

EXELA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1MG ZINC/ML

0

ZINC CHLORIDE

ZINC CHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

EXELA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212007
            [companyName] => EXELA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZINC CHLORIDE","activeIngredients":"ZINC CHLORIDE","strength":"EQ 1MG ZINC\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-21
        )

)