NDA 020389

BAYER HEALTHCARE LLC

FDA Drug Application

Application #020389

Application Sponsors

NDA 020389

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 002

Application Products

002

CREAM, TABLET;TOPICAL, VAGINAL

1%,100MG

0

MYCELEX-7 COMBINATION PACK

CLOTRIMAZOLE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

1994-06-23

STANDARD

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20389
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCELEX-7 COMBINATION PACK","activeIngredients":"CLOTRIMAZOLE","strength":"1%,100MG","dosageForm":"CREAM, TABLET;TOPICAL, VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCELEX-7 COMBINATION PACK","submission":"CLOTRIMAZOLE","actionType":"1%,100MG","submissionClassification":"CREAM, TABLET;TOPICAL, VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)