ANDA 215415

TEVA PHARMS INC

FDA Drug Application

Application #215415

Application Sponsors

ANDA 215415

TEVA 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

001	TABLET, CHEWABLE;ORAL	10MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
002	TABLET, CHEWABLE;ORAL	20MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
003	TABLET, CHEWABLE;ORAL	30MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
004	TABLET, CHEWABLE;ORAL	40MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
005	TABLET, CHEWABLE;ORAL	50MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE
006	TABLET, CHEWABLE;ORAL	60MG	0	LISDEXAMFETAMINE DIMESYLATE	LISDEXAMFETAMINE DIMESYLATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-11-25

UNKNOWN

Submissions Property Types

ORIG

1

Null

31

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
        )

)