ANDA 206983

X-GEN PHARMS INC

FDA Drug Application

Application #206983

Application Sponsors

ANDA 206983

X-GEN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;INHALATION

300MG/VIAL

0

PENTAMIDINE ISETHIONATE

PENTAMIDINE ISETHIONATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AN

CDER Filings

X-GEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206983
            [companyName] => X-GEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTAMIDINE ISETHIONATE","activeIngredients":"PENTAMIDINE ISETHIONATE","strength":"300MG\/VIAL","dosageForm":"FOR SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/20\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-20
        )

)