ANDA 091457

AM REGENT

FDA Drug Application

Application #091457

Application Sponsors

ANDA 091457

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

ZIDOVUDINE

ZIDOVUDINE

FDA Submissions

ORIG

1

AP

2010-05-06

Submissions Property Types

ORIG

1

Null

1

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91457
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIDOVUDINE","activeIngredients":"ZIDOVUDINE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZIDOVUDINE","submission":"ZIDOVUDINE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)