ANDA 204438

PAR PHARM INC

FDA Drug Application

Application #204438

Documents

• Letter: 2021-09-02

Application Sponsors

ANDA 204438

PAR PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

1MG/5ML

0

GLYCOPYRROLATE

GLYCOPYRROLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-07-23

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AA

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204438
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"1MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-09
        )

)