ANDA 210047

AMNEAL

FDA Drug Application

Application #210047

Application Sponsors

ANDA 210047

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 500MG BASE/VIAL

0

PEMETREXED DISODIUM

PEMETREXED DISODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210047
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PEMETREXED DISODIUM","submission":"PEMETREXED DISODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)