ANDA 074880

NEPHRON

FDA Drug Application

Application #074880

Application Sponsors

ANDA 074880

NEPHRON

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

EQ 0.083% BASE

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

	ORIG	1	AP	1997-09-17
LABELING; Labeling	SUPPL	2	AP	1998-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-07-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-10-29
LABELING; Labeling	SUPPL	7	AP	2000-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-06-06
LABELING; Labeling	SUPPL	12	AP	2007-03-28

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

TE Codes

001

Prescription

AN

CDER Filings

NEPHRON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74880
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.083% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [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
        )

)