ANDA 075409

HOSPIRA INC

FDA Drug Application

Application #075409

Documents

• Letter: 2004-06-09
• Letter: 2000-06-20

Application Sponsors

ANDA 075409

HOSPIRA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 5MG BASE/ML	0	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1MG BASE/ML	0	MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2000-06-20

Submissions Property Types

ORIG

1

Null

0

CDER Filings

HOSPIRA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75409
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MIDAZOLAM HYDROCHLORIDE","activeIngredients":"MIDAZOLAM HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MIDAZOLAM HYDROCHLORIDE","submission":"MIDAZOLAM HYDROCHLORIDE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)