TEVA PHARMS INC FDA Approval ANDA 215415

ANDA 215415

TEVA PHARMS INC

FDA Drug Application

Application #215415

Application Sponsors

ANDA 215415TEVA PHARMS INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004
None (Tentative Approval)005
None (Tentative Approval)006

Application Products

001TABLET, CHEWABLE;ORAL10MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
002TABLET, CHEWABLE;ORAL20MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
003TABLET, CHEWABLE;ORAL30MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
004TABLET, CHEWABLE;ORAL40MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
005TABLET, CHEWABLE;ORAL50MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
006TABLET, CHEWABLE;ORAL60MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE

FDA Submissions

UNKNOWN; ORIG1TA2022-11-25UNKNOWN

Submissions Property Types

ORIG1Null31

CDER Filings

TEVA PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215415
            [companyName] => TEVA PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"10MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"20MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"30MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"40MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"50MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"60MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-25
        )

)

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