X-GEN PHARMS INC FDA Approval ANDA 206983

ANDA 206983

X-GEN PHARMS INC

FDA Drug Application

Application #206983

Application Sponsors

ANDA 206983X-GEN PHARMS INC

Marketing Status

Prescription001

Application Products

001FOR SOLUTION;INHALATION300MG/VIAL0PENTAMIDINE ISETHIONATEPENTAMIDINE ISETHIONATE

FDA Submissions

UNKNOWN; ORIG1AP2023-01-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAN

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
        )

)

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