ANDA 091303

APOTEX INC

FDA Drug Application

Application #091303

Application Sponsors

ANDA 091303

APOTEX INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2.5MG

0

LETROZOLE

LETROZOLE

FDA Submissions

	ORIG	1	AP	2012-04-19
LABELING; Labeling	SUPPL	2	AP	2019-05-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-05-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91303
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LETROZOLE","activeIngredients":"LETROZOLE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LETROZOLE","submission":"LETROZOLE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)