ANDA 205710

CIPLA

FDA Drug Application

Application #205710

Application Sponsors

ANDA 205710

CIPLA

Marketing Status

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

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-11-16	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-04-06	STANDARD
LABELING; Labeling	SUPPL	17	AP	2021-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	9	Null	15
SUPPL	17	Null	7

TE Codes

001	Prescription	AN
002	Prescription	AN
003	Prescription	AN

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205710
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUDESONIDE","activeIngredients":"BUDESONIDE","strength":"0.25MG\/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":"1MG\/2ML","dosageForm":"SUSPENSION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/16\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-16
        )

)