NANG KUANG PHARM CO FDA Approval ANDA 207352

ANDA 207352

NANG KUANG PHARM CO

FDA Drug Application

Application #207352

Application Sponsors

ANDA 207352NANG KUANG PHARM CO

Marketing Status

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

Application Products

001POWDER;INTRAVENOUSEQ 100MG BASE/VIAL0PEMETREXED DISODIUMPEMETREXED DISODIUM
002POWDER;INTRAVENOUSEQ 500MG BASE/VIAL0PEMETREXED DISODIUMPEMETREXED DISODIUM

FDA Submissions

UNKNOWN; ORIG1TA2019-10-17STANDARD

Submissions Property Types

ORIG1Null31

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

NANG KUANG PHARM CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207352
            [companyName] => NANG KUANG PHARM CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED SODIUM","activeIngredients":"PEMETREXED SODIUM","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/17\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-17
        )

)

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