ANDA 201276

MYLAN INSTITUTIONAL

FDA Drug Application

Application #201276

Documents

• Review: 2013-02-26

Application Sponsors

ANDA 201276

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 75MG BASE/ML

0

CIDOFOVIR

CIDOFOVIR

FDA Submissions

ORIG

1

AP

2012-06-27

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201276
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIDOFOVIR","activeIngredients":"CIDOFOVIR","strength":"EQ 75MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/201276Orig1s000Approv.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-06-27
        )

)