ANDA 206982

XGEN PHARMS

FDA Drug Application

Application #206982

Application Sponsors

ANDA 206982

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

300MG/VIAL

0

PENTAMIDINE ISETHIONATE

PENTAMIDINE ISETHIONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-03-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206982
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTAMIDINE ISETHIONATE","activeIngredients":"PENTAMIDINE ISETHIONATE","strength":"300MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-17
        )

)