ANDA 078623

APOTEX INC

FDA Drug Application

Application #078623

Application Sponsors

ANDA 078623

APOTEX INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	SOLUTION;INHALATION	EQ 0.021% BASE	0	ALBUTEROL SULFATE	ALBUTEROL SULFATE
002	SOLUTION;INHALATION	EQ 0.042% BASE	0	ALBUTEROL SULFATE	ALBUTEROL SULFATE

FDA Submissions

ORIG

1

AP

2010-04-05

Submissions Property Types

SUPPL

1

Null

15

CDER Filings

APOTEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78623
            [companyName] => APOTEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.021% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.042% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.021% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.042% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)