AM REGENT FDA Approval ANDA 091329

ANDA 091329

AM REGENT

FDA Drug Application

Application #091329

Application Sponsors

ANDA 091329AM REGENT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION100MG/ML0TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREETRIMETHOBENZAMIDE HYDROCHLORIDE

FDA Submissions

ORIG1AP2011-03-08

Submissions Property Types

ORIG1Null7

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91329
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"TRIMETHOBENZAMIDE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE","submission":"TRIMETHOBENZAMIDE HYDROCHLORIDE","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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