PLIVA FDA Approval ANDA 076426

ANDA 076426

PLIVA

FDA Drug Application

Application #076426

Application Sponsors

ANDA 076426PLIVA

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORALEQ 100MG BASE0CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDE
002TABLET;ORALEQ 250MG BASE0CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDE
003TABLET;ORALEQ 500MG BASE0CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDE
004TABLET;ORALEQ 750MG BASE0CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDE

FDA Submissions

ORIG1AP2005-06-15

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76426
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 750MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 750MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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