ANDA 204522

PAR PHARM INC

FDA Drug Application

Application #204522

Documents

• Letter: 2017-01-30

Application Sponsors

ANDA 204522

PAR PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

10MG

0

PHENOXYBENZAMINE HYDROCHLORIDE

PHENOXYBENZAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-01-24

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AB

CDER Filings

PAR PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204522
            [companyName] => PAR PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENOXYBENZAMINE HYDROCHLORIDE","activeIngredients":"PHENOXYBENZAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/24\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204522Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-24
        )

)