ANDA 091623

MYLAN INSTITUTIONAL

FDA Drug Application

Application #091623

Documents

• Review: 2013-02-27

Application Sponsors

ANDA 091623

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

THIAMINE HYDROCHLORIDE

THIAMINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2012-06-25

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91623
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIAMINE HYDROCHLORIDE","activeIngredients":"THIAMINE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THIAMINE HYDROCHLORIDE","submission":"THIAMINE HYDROCHLORIDE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)