SUN PHARM INDS INC FDA Approval ANDA 040897

ANDA 040897

SUN PHARM INDS INC

FDA Drug Application

Application #040897

Application Sponsors

ANDA 040897SUN PHARM INDS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001TABLET;ORAL5MG0BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE
002TABLET;ORAL10MG0BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE
003TABLET;ORAL25MG0BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE
004TABLET;ORAL50MG0BETHANECHOL CHLORIDEBETHANECHOL CHLORIDE

FDA Submissions

ORIG1AP2009-04-22

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40897
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETHANECHOL CHLORIDE","activeIngredients":"BETHANECHOL CHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BETHANECHOL CHLORIDE","activeIngredients":"BETHANECHOL CHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BETHANECHOL CHLORIDE","activeIngredients":"BETHANECHOL CHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BETHANECHOL CHLORIDE","activeIngredients":"BETHANECHOL CHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETHANECHOL CHLORIDE","submission":"BETHANECHOL CHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BETHANECHOL CHLORIDE","submission":"BETHANECHOL CHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BETHANECHOL CHLORIDE","submission":"BETHANECHOL CHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BETHANECHOL CHLORIDE","submission":"BETHANECHOL CHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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