ANDA 215479

HONG KONG

FDA Drug Application

Application #215479

Application Sponsors

ANDA 215479

HONG KONG

Marketing Status

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

Application Products

001	POWDER;INTRAVENOUS	EQ 100MG BASE/VIAL	0	PEMETREXED DISODIUM	PEMETREXED DISODIUM
002	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL	0	PEMETREXED DISODIUM	PEMETREXED DISODIUM
003	POWDER;INTRAVENOUS	EQ 750MG BASE/VIAL	0	PEMETREXED DISODIUM	PEMETREXED DISODIUM
004	POWDER;INTRAVENOUS	EQ 1GM BASE/VIAL	0	PEMETREXED DISODIUM	PEMETREXED DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

HONG KONG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215479
            [companyName] => HONG KONG
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 750MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-13
        )

)