NESHER PHARMS FDA Approval ANDA 076193

ANDA 076193

NESHER PHARMS

FDA Drug Application

Application #076193

Application Sponsors

ANDA 076193NESHER PHARMS

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL150MG0PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
002TABLET;ORAL225MG0PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
003TABLET;ORAL300MG0PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE

FDA Submissions

ORIG1AP2002-02-07

Submissions Property Types

ORIG1Null0

CDER Filings

NESHER PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76193
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"225MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPAFENONE HYDROCHLORIDE","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROPAFENONE HYDROCHLORIDE","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"225MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROPAFENONE HYDROCHLORIDE","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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