ANDA 076749

NEPHRON

FDA Drug Application

Application #076749

Application Sponsors

ANDA 076749

NEPHRON

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INHALATION	EQ 0.083% BASE;0.017%	0	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
002	SOLUTION; INHALATION	0.5MG; 0.017%	0	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

FDA Submissions

	ORIG	1	AP	2007-12-31
LABELING; Labeling	SUPPL	12	AP	2011-12-13
LABELING; Labeling	SUPPL	14	AP	2012-08-13	STANDARD

Submissions Property Types

SUPPL	12	Null	15
SUPPL	14	Null	15

TE Codes

001

Prescription

AN

CDER Filings

NEPHRON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76749
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE","activeIngredients":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","strength":"EQ 0.083% BASE;0.017%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","activeIngredients":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","strength":"0.5MG; 0.017%","dosageForm":"SOLUTION; INHALATION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE","submission":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","actionType":"EQ 0.083% BASE;0.017%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","submission":"ALBUTEROL SULFATE; IPRATROPIUM BROMIDE","actionType":"0.5MG; 0.017%","submissionClassification":"SOLUTION; INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)