ANDA 214547

NORWICH

FDA Drug Application

Application #214547

Documents

• Letter: 2022-11-28

Application Sponsors

ANDA 214547

NORWICH

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

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-06-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

NORWICH

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(
    [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
        )

)