ANDA 201966

SANDOZ INC

FDA Drug Application

Application #201966

Application Sponsors

ANDA 201966

SANDOZ INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SUSPENSION;INHALATION	1MG/2ML	0	BUDESONIDE	BUDESONIDE
002	SUSPENSION;INHALATION	0.5MG/2ML	0	BUDESONIDE	BUDESONIDE
003	SUSPENSION;INHALATION	0.25MG/2ML	0	BUDESONIDE	BUDESONIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2013-09-27
LABELING; Labeling	SUPPL	9	AP	2021-03-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	9	Null	7

TE Codes

001	Prescription	AN
002	Prescription	AN
003	Prescription	AN

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201966
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"1MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.5MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.25MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-09-27
        )

)