NDA 208297

DR REDDYS LABS INC

FDA Drug Application

Application #208297

Documents

• Letter: 2020-05-15

Application Sponsors

NDA 208297

DR REDDYS LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	100MG	0	PEMETREXED FOR INJECTION	PEMETREXED
002	INJECTABLE;INJECTION	500MG	0	PEMETREXED FOR INJECTION	PEMETREXED
003	INJECTABLE;INJECTION	1G	0	PEMETREXED FOR INJECTION	PEMETREXED

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2020-05-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

DR REDDYS LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208297
            [companyName] => DR REDDYS LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED FOR INJECTION","activeIngredients":"PEMETREXED","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED FOR INJECTION","activeIngredients":"PEMETREXED","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED FOR INJECTION","activeIngredients":"PEMETREXED","strength":"1G","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/14\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208297Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-14
        )

)