ZYDUS PHARMS USA INC FDA Approval ANDA 214073

ANDA 214073

ZYDUS PHARMS USA INC

FDA Drug Application

Application #214073

Application Sponsors

ANDA 214073ZYDUS PHARMS USA INC

Marketing Status

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

Application Products

001POWDER;INTRAVENOUSEQ 100MG BASE/VIAL0PEMETREXED DISODIUMPEMETREXED DISODIUM
002POWDER;INTRAVENOUSEQ 500MG BASE/VIAL0PEMETREXEDPEMETREXED DISODIUM
003POWDER;INTRAVENOUSEQ 1GM BASE/VIAL0PEMETREXEDPEMETREXED DISODIUM

FDA Submissions

UNKNOWN; ORIG1TA2021-06-24STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

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
        )

)

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