ANDA 076355

NEPHRON

FDA Drug Application

Application #076355

Application Sponsors

ANDA 076355

NEPHRON

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	2004-06-28
LABELING; Labeling	SUPPL	4	AP	2007-03-29
LABELING; Labeling	SUPPL	7	AP	2010-03-31
LABELING; Labeling	SUPPL	12	AP	2011-09-13

Submissions Property Types

SUPPL	7	Null	7
SUPPL	12	Null	15

TE Codes

001	Prescription	AN
002	Prescription	AN

CDER Filings

NEPHRON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76355
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.042% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.021% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.042% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.021% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)