ANDA 214073

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214073

Application Sponsors

ANDA 214073

ZYDUS PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-06-24

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214073
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 100MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/24\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-24
        )

)