ANDA 040312

NOVO NORDISK INC

FDA Drug Application

Application #040312

Documents

• Letter: 1999-11-19
• Review: 1999-11-19

Application Sponsors

ANDA 040312

NOVO NORDISK INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	0.5MG	0	INNOFEM	ESTRADIOL
002	TABLET;ORAL	1MG	0	INNOFEM	ESTRADIOL
003	TABLET;ORAL	2MG	0	INNOFEM	ESTRADIOL

FDA Submissions

	ORIG	1	AP	1999-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-07-15

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

NOVO NORDISK INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40312
            [companyName] => NOVO NORDISK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"INNOFEM","activeIngredients":"ESTRADIOL","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"INNOFEM","activeIngredients":"ESTRADIOL","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"INNOFEM","activeIngredients":"ESTRADIOL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"INNOFEM","submission":"ESTRADIOL","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"INNOFEM","submission":"ESTRADIOL","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"INNOFEM","submission":"ESTRADIOL","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)