ANDA 201050

HIKMA

FDA Drug Application

Application #201050

Documents

• Letter: 2012-07-18
• Review: 2018-02-27

Application Sponsors

ANDA 201050

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

10MG

0

PHENOXYBENZAMINE HYDROCHLORIDE

PHENOXYBENZAMINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2012-07-16

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201050
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENOXYBENZAMINE HYDROCHLORIDE","activeIngredients":"PHENOXYBENZAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/16\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201050Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/201050Orig1s000.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-07-16
        )

)