ANDA 202596

DR REDDYS LABS LTD

FDA Drug Application

Application #202596

Application Sponsors

ANDA 202596

DR REDDYS LABS LTD

Marketing Status

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

Application Products

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

2019-08-16

Submissions Property Types

ORIG

1

Null

42

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202596
            [companyName] => DR REDDYS LABS LTD
            [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":"08\/16\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-16
        )

)