ANDA 216462

GLENMARK PHARMS LTD

FDA Drug Application

Application #216462

Application Sponsors

ANDA 216462

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

500MG

0

SODIUM PHENYLBUTYRATE

SODIUM PHENYLBUTYRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-01

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216462
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PHENYLBUTYRATE","activeIngredients":"SODIUM PHENYLBUTYRATE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-01
        )

)