ANDA 040843

PHARMACHEMIE BV

FDA Drug Application

Application #040843

Application Sponsors

ANDA 040843

PHARMACHEMIE BV

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	0	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM
002	INJECTABLE;INJECTION	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	0	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM
003	INJECTABLE;INJECTION	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	0	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM
004	INJECTABLE;INJECTION	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	0	METHOTREXATE SODIUM PRESERVATIVE FREE	METHOTREXATE SODIUM

FDA Submissions

	ORIG	1	AP	2010-01-08
LABELING; Labeling	SUPPL	5	AP	2017-02-24	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-08-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-08-02	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	5	Null	15
SUPPL	7	Null	15
SUPPL	11	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
004	Prescription	AP

CDER Filings

PHARMACHEMIE BV

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40843
            [companyName] => PHARMACHEMIE BV
            [docInserts] => ["",""]
            [products] => [{"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"},{"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 100MG BASE\/4ML (EQ 25MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHOTREXATE SODIUM PRESERVATIVE FREE","submission":"METHOTREXATE SODIUM","actionType":"EQ 1GM BASE\/40ML (EQ 25MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHOTREXATE SODIUM PRESERVATIVE FREE","submission":"METHOTREXATE SODIUM","actionType":"EQ 50MG BASE\/2ML (EQ 25MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHOTREXATE SODIUM PRESERVATIVE FREE","submission":"METHOTREXATE SODIUM","actionType":"EQ 100MG BASE\/4ML (EQ 25MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHOTREXATE SODIUM PRESERVATIVE FREE","submission":"METHOTREXATE SODIUM","actionType":"EQ 250MG BASE\/10ML (EQ 25MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)