NDA 021103

NOVO NORDISK

FDA Drug Application

Application #021103

Documents

• Letter: 2000-04-11
• Label: 2000-04-11
• Review: 2007-11-06

Application Sponsors

NDA 021103

NOVO NORDISK

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

1MG/0.5MG

0

ACTIVELLA

ESTRADIOL; NORETHINDRONE ACETATE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2000-04-11

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

NOVO NORDISK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21103
            [companyName] => NOVO NORDISK
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACTIVELLA","activeIngredients":"ESTRADIOL; NORETHINDRONE ACETATE","strength":"1MG\/0.5MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/11\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21103lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACTIVELLA","submission":"ESTRADIOL; NORETHINDRONE ACETATE","actionType":"1MG\/0.5MG","submissionClassification":"TABLET; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-04-11
        )

)