ANDA 203653

RITEDOSE CORP

FDA Drug Application

Application #203653

Application Sponsors

ANDA 203653

RITEDOSE CORP

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

2016-03-22

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AN
002	Prescription	AN
003	Prescription	AN

CDER Filings

RITEDOSE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203653
            [companyName] => RITEDOSE CORP
            [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":"03\/22\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-22
        )

)