ANDA 201379

SAGENT PHARMS INC

FDA Drug Application

Application #201379

Documents

• Letter: 2017-03-03

Application Sponsors

ANDA 201379

SAGENT PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG BASE/VIAL

0

MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2017-02-28

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201379
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELPHALAN HYDROCHLORIDE","activeIngredients":"MELPHALAN HYDROCHLORIDE","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201379Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-02-28
        )

)