ANDA 209767

ALVOGEN PINE BROOK

FDA Drug Application

Application #209767

Application Sponsors

ANDA 209767

ALVOGEN PINE BROOK

Marketing Status

• Prescription: 001

Application Products

001

CREAM;VAGINAL

0.01%

0

ESTRADIOL

ESTRADIOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-05

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN PINE BROOK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209767
            [companyName] => ALVOGEN PINE BROOK
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESTRADIOL","activeIngredients":"ESTRADIOL","strength":"0.01%","dosageForm":"CREAM;VAGINAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/15\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-08-15
        )

)