ANDA 202402

XGEN PHARMS

FDA Drug Application

Application #202402

Documents

• Letter: 2016-04-01
• Label: 2016-04-11

Application Sponsors

ANDA 202402

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

0

IBUPROFEN LYSINE

IBUPROFEN LYSINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-03-30

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

XGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202402
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN LYSINE","activeIngredients":"IBUPROFEN LYSINE","strength":"EQ 20MG BASE\/2ML (EQ 10MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/30\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202402Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202402Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202402Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-03-30
        )

)