NDA 021788

TEVA WOMENS

FDA Drug Application

Application #021788

Documents

• Label: 2008-12-03
• Letter: 2008-12-02
• Review: 2009-04-22

Application Sponsors

NDA 021788

TEVA WOMENS

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;VAGINAL

0.625MG/GM

0

SYNTHETIC CONJUGATED ESTROGENS A

ESTROGENS, CONJUGATED SYNTHETIC A

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2008-11-28

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

TEVA WOMENS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21788
            [companyName] => TEVA WOMENS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SYNTHETIC CONJUGATED ESTROGENS A","activeIngredients":"ESTROGENS, CONJUGATED SYNTHETIC A","strength":"0.625MG\/GM","dosageForm":"CREAM;VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/28\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021788lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SYNTHETIC CONJUGATED ESTROGENS A","submission":"ESTROGENS, CONJUGATED SYNTHETIC A","actionType":"0.625MG\/GM","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2008-11-28
        )

)