ANDA 216324

AM REGENT

FDA Drug Application

Application #216324

Documents

• Letter: 2023-01-10

Application Sponsors

ANDA 216324

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.4MG COPPER/ML

0

CUPRIC SULFATE

CUPRIC SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216324
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CUPRIC SULFATE","activeIngredients":"CUPRIC SULFATE","strength":"EQ 0.4MG COPPER\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-16
        )

)