ANDA 200898

ALVOGEN

FDA Drug Application

Application #200898

Application Sponsors

ANDA 200898

ALVOGEN

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

EXEMESTANE

EXEMESTANE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-07-28
LABELING; Labeling	SUPPL	6	AP	2019-02-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-02-22	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	6	Null	7
SUPPL	10	Null	15

TE Codes

001

Prescription

AB

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200898
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXEMESTANE","activeIngredients":"EXEMESTANE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/28\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/22\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/22\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-02-22
        )

)