ANDA 203166

NEXGEN PHARMA INC

FDA Drug Application

Application #203166

Documents

• Letter: 2019-09-27

Application Sponsors

ANDA 203166

NEXGEN PHARMA INC

Marketing Status

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

Application Products

001	TABLET;ORAL	500MG	0	NABUMETONE	NABUMETONE
002	TABLET;ORAL	750MG	0	NABUMETONE	NABUMETONE
003	TABLET;ORAL	1GM	0	NABUMETONE	NABUMETONE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-08-30
LABELING; Labeling	SUPPL	3	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NEXGEN PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203166
            [companyName] => NEXGEN PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NABUMETONE","activeIngredients":"NABUMETONE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203166Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-30
        )

)