ANDA 203407

SAGENT PHARMS INC

FDA Drug Application

Application #203407

Application Sponsors

ANDA 203407

SAGENT PHARMS INC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	0	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM
002	INJECTABLE;INJECTION	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	0	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM
003	INJECTABLE;INJECTION	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	0	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-09

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

SAGENT PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203407
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOTREXATE SODIUM PRESERVATIVE FREE","activeIngredients":"METHOTREXATE SODIUM","strength":"EQ 50MG BASE\/2ML (EQ 25MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHOTREXATE SODIUM PRESERVATIVE FREE","activeIngredients":"METHOTREXATE SODIUM","strength":"EQ 250MG BASE\/10ML (EQ 25MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHOTREXATE SODIUM PRESERVATIVE FREE","activeIngredients":"METHOTREXATE SODIUM","strength":"EQ 1GM BASE\/40ML (EQ 25MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-09
        )

)