ANDA 209309

LUPIN LTD

FDA Drug Application

Application #209309

Application Sponsors

ANDA 209309

LUPIN LTD

Marketing Status

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

Application Products

001	TABLET;ORAL	20MG	0	NADOLOL	NADOLOL
002	TABLET;ORAL	40MG	0	NADOLOL	NADOLOL
003	TABLET;ORAL	80MG	0	NADOLOL	NADOLOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209309
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NADOLOL","activeIngredients":"NADOLOL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NADOLOL","activeIngredients":"NADOLOL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NADOLOL","activeIngredients":"NADOLOL","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-05
        )

)