NORWICH FDA Approval ANDA 214547

ANDA 214547

NORWICH

FDA Drug Application

Application #214547

Application Sponsors

ANDA 214547NORWICH

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
None (Tentative Approval)007

Application Products

002CAPSULE; ORAL20mg0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
003CAPSULE; ORAL30mg0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
004CAPSULE; ORAL40mg0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
005CAPSULE; ORAL50mg0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
006CAPSULE; ORAL60mg0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE
007CAPSULE; ORAL70mg0LISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE

FDA Submissions

UNKNOWN; ORIG1TA2022-06-21STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

NORWICH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214547
            [companyName] => NORWICH
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISDEXAMFETAMINE DIMESYLATE","activeIngredients":"LISDEXAMFETAMINE DIMESYLATE","strength":"10mg","dosageForm":"CAPSULE; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"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":"06\/21\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-06-21
        )

)

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