ANDA 090137

SANDOZ INC

FDA Drug Application

Application #090137

Application Sponsors

ANDA 090137

SANDOZ INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	40MG/2ML (20MG/ML)	0	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE
002	INJECTABLE;INJECTION	100MG/5ML (20MG/ML)	0	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2009-11-12

Submissions Property Types

ORIG

1

Null

7

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90137
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"40MG\/2ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IRINOTECAN HYDROCHLORIDE","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"40MG\/2ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IRINOTECAN HYDROCHLORIDE","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"100MG\/5ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)