ANDA 203485

ACCORD HLTHCARE INC

FDA Drug Application

Application #203485

Application Sponsors

ANDA 203485

ACCORD HLTHCARE INC

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-10-27

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

ACCORD HLTHCARE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203485
            [companyName] => ACCORD HLTHCARE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED DISODIUM","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-10-27
        )

)