FRESENIUS KABI USA FDA Approval ANDA 091376

ANDA 091376

FRESENIUS KABI USA

FDA Drug Application

Application #091376

Documents

Letter2010-12-03

Application Sponsors

ANDA 091376FRESENIUS KABI USA

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 4MG BASE/VIAL0TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDE

FDA Submissions

ORIG1AP2010-11-29

Submissions Property Types

ORIG1Null42

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91376
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOPOTECAN HYDROCHLORIDE","activeIngredients":"TOPOTECAN HYDROCHLORIDE","strength":"EQ 4MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOPOTECAN HYDROCHLORIDE","submission":"TOPOTECAN HYDROCHLORIDE","actionType":"EQ 4MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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