ANDA 205789

NEXGEN PHARMA INC

FDA Drug Application

Application #205789

Documents

• Letter: 2020-06-04

Application Sponsors

ANDA 205789

NEXGEN PHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	200MG	0	URSODIOL	URSODIOL
002	CAPSULE;ORAL	400MG	0	URSODIOL	URSODIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

NEXGEN PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205789
            [companyName] => NEXGEN PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"URSODIOL","activeIngredients":"URSODIOL","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"URSODIOL","activeIngredients":"URSODIOL","strength":"400MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/205789Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-08
        )

)