ANDA 205742

PAR PHARM INC

FDA Drug Application

Application #205742

Documents

• Letter: 2022-01-12

Application Sponsors

ANDA 205742

PAR PHARM INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

LIQUID;ORAL

1.1GRAMS/ML

0

GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-05-19

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AA

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205742
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCEROL PHENYLBUTYRATE","activeIngredients":"GLYCEROL PHENYLBUTYRATE","strength":"1.1GRAMS\/ML","dosageForm":"LIQUID;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/19\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-05-19
        )

)