EUROHLTH INTL SARL FDA Approval ANDA 074885

ANDA 074885

EUROHLTH INTL SARL

FDA Drug Application

Application #074885

Application Sponsors

ANDA 074885EUROHLTH INTL SARL

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREEACYCLOVIR SODIUM
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREEACYCLOVIR SODIUM

FDA Submissions

ORIG1AP1997-12-19

CDER Filings

EUROHLTH INTL SARL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74885
            [companyName] => EUROHLTH INTL SARL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE","activeIngredients":"ACYCLOVIR SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE","activeIngredients":"ACYCLOVIR SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE","submission":"ACYCLOVIR SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE","submission":"ACYCLOVIR SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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