ANDA 075562

NEPHRON

FDA Drug Application

Application #075562

Documents

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

Application Sponsors

ANDA 075562

NEPHRON

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INHALATION

0.02%

0

IPRATROPIUM BROMIDE

IPRATROPIUM BROMIDE

FDA Submissions

ORIG

1

AP

2001-09-27

TE Codes

001

Prescription

AN

CDER Filings

NEPHRON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75562
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"IPRATROPIUM BROMIDE","activeIngredients":"IPRATROPIUM BROMIDE","strength":"0.02%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IPRATROPIUM BROMIDE","submission":"IPRATROPIUM BROMIDE","actionType":"0.02%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)