NDA 215401

NOVEN PHARMS INC

FDA Drug Application

Application #215401

Documents

• Letter: 2022-03-23
• Label: 2022-03-25
• Review: 2022-05-04
• Letter: 2022-08-17
• Label: 2022-08-17

Application Sponsors

NDA 215401

NOVEN PHARMS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	SYSTEM; TRANSDERMAL	4.5MG/9HR	0	XELSTRYM	DEXTROAMPHETAMINE
002	SYSTEM; TRANSDERMAL	9MG/9HR	0	XELSTRYM	DEXTROAMPHETAMINE
003	SYSTEM;TRANSDERMAL	13.5MG/9HR	0	XELSTRYM	DEXTROAMPHETAMINE
004	SYSTEM;TRANSDERMAL	18.5MG/9HR	0	XELSTRYM	DEXTROAMPHETAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-03-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

NOVEN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215401
            [companyName] => NOVEN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"XELSTRYM","activeIngredients":"DEXTROAMPHETAMINE","strength":"4.5MG\/9HR","dosageForm":"SYSTEM; TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"XELSTRYM","activeIngredients":"DEXTROAMPHETAMINE","strength":"9MG\/9HR","dosageForm":"SYSTEM; TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"XELSTRYM","activeIngredients":"DEXTROAMPHETAMINE","strength":"13.5MG\/9HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"XELSTRYM","activeIngredients":"DEXTROAMPHETAMINE","strength":"18.5MG\/9HR","dosageForm":"SYSTEM;TRANSDERMAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215401s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215401s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215401Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-22
        )

)