ANDA 201618

DR REDDYS

FDA Drug Application

Application #201618

Application Sponsors

ANDA 201618

DR REDDYS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	40MG	0	VALSARTAN	VALSARTAN
002	TABLET;ORAL	80MG	0	VALSARTAN	VALSARTAN
003	TABLET;ORAL	160MG	0	VALSARTAN	VALSARTAN
004	TABLET;ORAL	320MG	0	VALSARTAN	VALSARTAN

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2021-10-05

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201618
            [companyName] => DR REDDYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"160MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"320MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-05
        )

)