ANDA 209208

UPSHER SMITH LABS

FDA Drug Application

Application #209208

Application Sponsors

ANDA 209208

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

EXEMESTANE

EXEMESTANE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-07-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-02-22	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-10-27	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	7	Null	7

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209208
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXEMESTANE","activeIngredients":"EXEMESTANE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/26\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/22\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-02-22
        )

)