ANDA 078949

APOTEX INC

FDA Drug Application

Application #078949

Application Sponsors

ANDA 078949

APOTEX INC

Marketing Status

• Prescription: 001
• Over-the-counter: 002

Application Products

001	SPRAY, METERED;NASAL	0.032MG/INH	0	BUDESONIDE	BUDESONIDE
002	SPRAY, METERED;NASAL	0.032MG/SPRAY	0	BUDESONIDE	BUDESONIDE

FDA Submissions

	ORIG	1	AP	2014-05-12
LABELING; Labeling	SUPPL	3	AP	2015-11-20	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	3
SUPPL	3	Null	15
SUPPL	10	Null	7

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78949
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.032MG\/INH","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.032MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUDESONIDE","submission":"BUDESONIDE","actionType":"0.032MG\/INH","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BUDESONIDE","submission":"BUDESONIDE","actionType":"0.032MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)