ANDA 207820

SUN PHARM

FDA Drug Application

Application #207820

Application Sponsors

ANDA 207820

SUN PHARM

Marketing Status

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

Application Products

001	SOLUTION;INHALATION	EQ 0.0103% BASE	0	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE
002	SOLUTION;INHALATION	EQ 0.021% BASE	0	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE
003	SOLUTION;INHALATION	EQ 0.042% BASE	0	LEVALBUTEROL HYDROCHLORIDE	LEVALBUTEROL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-05	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-12-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AN
002	Prescription	AN
003	Prescription	AN

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207820
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVALBUTEROL HYDROCHLORIDE","activeIngredients":"LEVALBUTEROL HYDROCHLORIDE","strength":"EQ 0.0103% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVALBUTEROL HYDROCHLORIDE","activeIngredients":"LEVALBUTEROL HYDROCHLORIDE","strength":"EQ 0.021% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVALBUTEROL HYDROCHLORIDE","activeIngredients":"LEVALBUTEROL HYDROCHLORIDE","strength":"EQ 0.042% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/20\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-20
        )

)