ANDA 203455

INVAGEN PHARMS

FDA Drug Application

Application #203455

Documents

• Letter: 2015-12-22

Application Sponsors

ANDA 203455

INVAGEN PHARMS

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

2015-12-18

Submissions Property Types

ORIG

1

Null

17

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203455
            [companyName] => INVAGEN PHARMS
            [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":"12\/18\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203455Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-18
        )

)