ANDA 202836

SANDOZ INC

FDA Drug Application

Application #202836

Application Sponsors

ANDA 202836

SANDOZ 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

001	CAPSULE;ORAL	20MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
002	CAPSULE;ORAL	30MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
003	CAPSULE;ORAL	40MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
004	CAPSULE;ORAL	50MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
005	CAPSULE;ORAL	60MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
006	CAPSULE;ORAL	70MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-08-17

Submissions Property Types

ORIG

1

Null

19

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
        )

)