ANDA 212548

XIROMED

FDA Drug Application

Application #212548

Documents

• Letter: 2020-12-07

Application Sponsors

ANDA 212548

XIROMED

Marketing Status

• Prescription: 001

Application Products

001

FOR SOLUTION;ORAL

EQ 3GM BASE/PACKET

0

FOSFOMYCIN TROMETHAMINE

FOSFOMYCIN TROMETHAMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-06

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

XIROMED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212548
            [companyName] => XIROMED
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSFOMYCIN TROMETHAMINE","activeIngredients":"FOSFOMYCIN TROMETHAMINE","strength":"EQ 3GM BASE\/PACKET","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-06
        )

)