ANDA 208696

JIANGSU HANSOH PHARM

FDA Drug Application

Application #208696

Application Sponsors

ANDA 208696

JIANGSU HANSOH PHARM

Marketing Status

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

Application Products

001	POWDER;INTRAVENOUS	EQ 100MG BASE/VIAL	0	PEMETREXED	PEMETREXED
002	POWDER;INTRAVENOUS	EQ 500MG BASE/VIAL	0	PEMETREXED	PEMETREXED

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-12-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

JIANGSU HANSOH PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208696
            [companyName] => JIANGSU HANSOH PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"EQ 100MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"EQ 500MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-28
        )

)