ANDA 201746

XGEN PHARMS

FDA Drug Application

Application #201746

Documents

• Letter: 2015-06-10

Application Sponsors

ANDA 201746

XGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 300MG BASE/ML

0

LINCOMYCIN

LINCOMYCIN HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2015-06-04

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

XGEN PHARMS

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(
    [0] => Array
        (
            [ApplNo] => 201746
            [companyName] => XGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINCOMYCIN","activeIngredients":"LINCOMYCIN HYDROCHLORIDE","strength":"EQ 300MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201746Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-06-04
        )

)