ANDA 075664

NEPHRON

FDA Drug Application

Application #075664

Documents

• Letter: 2003-04-14
• Review: 2005-07-22

Application Sponsors

ANDA 075664

NEPHRON

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

EQ 0.5% BASE

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

	ORIG	1	AP	2001-06-26
LABELING; Labeling	SUPPL	2	AP	2007-03-29

TE Codes

001

Prescription

AN

CDER Filings

NEPHRON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75664
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.5% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)