ANDA 208521

MAIA PHARMS INC

FDA Drug Application

Application #208521

Documents

• Letter: 2017-05-10

Application Sponsors

ANDA 208521

MAIA PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

10%;10% (5GM/50ML;5GM/50ML)

0

SODIUM PHENYLACETATE AND SODIUM BENZOATE

SODIUM BENZOATE; SODIUM PHENYLACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MAIA PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208521
            [companyName] => MAIA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PHENYLACETATE AND SODIUM BENZOATE","activeIngredients":"SODIUM BENZOATE; SODIUM PHENYLACETATE","strength":"10%;10% (5GM\/50ML;5GM\/50ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208521Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-08
        )

)