SANDOZ INC FDA Approval ANDA 202836

ANDA 202836

SANDOZ INC

FDA Drug Application

Application #202836

Application Sponsors

ANDA 202836SANDOZ 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

001CAPSULE;ORAL20MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
002CAPSULE;ORAL30MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
003CAPSULE;ORAL40MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
004CAPSULE;ORAL50MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
005CAPSULE;ORAL60MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
006CAPSULE;ORAL70MG0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE

FDA Submissions

UNKNOWN; ORIG1TA2015-08-17

Submissions Property Types

ORIG1Null19

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202836
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"60MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"70MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/17\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-08-17
        )

)

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