PHATHOM PHARMACEUTICALS, INC FDA Approval NDA 215152

NDA 215152

PHATHOM PHARMACEUTICALS, INC

FDA Drug Application

Application #215152

Documents

Letter2022-05-04
Label2022-05-06
Review2022-06-08

Application Sponsors

NDA 215152PHATHOM PHARMACEUTICALS, INC

Marketing Status

Prescription001

Application Products

001CAPSULE, TABLET, TABLET500MG; 500MG; 20MG2VOQUEZNA TRIPLE PAKAMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2022-05-03PRIORITY

Submissions Property Types

ORIG1Null40

TE Codes

001PrescriptionTBD

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215152
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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