ANDA 076025

BAUSCH AND LOMB

FDA Drug Application

Application #076025

Documents

• Review: 2007-09-26

Application Sponsors

ANDA 076025

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.021MG/SPRAY

0

IPRATROPIUM BROMIDE

IPRATROPIUM BROMIDE

FDA Submissions

	ORIG	1	AP	2003-03-31
LABELING; Labeling	SUPPL	4	AP	2007-12-20
LABELING; Labeling	SUPPL	6	AP	2012-02-06

Submissions Property Types

SUPPL

6

Null

15

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76025
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"IPRATROPIUM BROMIDE","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.021MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IPRATROPIUM BROMIDE","submission":"IPRATROPIUM BROMIDE","actionType":"0.021MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)