ANDA 077839

RITEDOSE CORP

FDA Drug Application

Application #077839

Application Sponsors

ANDA 077839

RITEDOSE CORP

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

EQ 0.083% BASE

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

	ORIG	1	AP	2008-12-16
LABELING; Labeling	SUPPL	13	AP	2013-01-28	STANDARD

Submissions Property Types

SUPPL

13

Null

15

TE Codes

001

Prescription

AN

CDER Filings

RITEDOSE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77839
            [companyName] => RITEDOSE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.083% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.083% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)