ANDA 211922

SUN PHARM

FDA Drug Application

Application #211922

Application Sponsors

ANDA 211922

SUN PHARM

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

2021-04-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AN
002	Prescription	AN
003	Prescription	AN

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211922
            [companyName] => SUN PHARM
            [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":"04\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-14
        )

)