AM REGENT FDA Approval ANDA 072489

ANDA 072489

AM REGENT

FDA Drug Application

Application #072489

Application Sponsors

ANDA 072489AM REGENT

Marketing Status

Prescription001

Application Products

001SOLUTION;INHALATION, ORAL10%0ACETYLCYSTEINEACETYLCYSTEINE

FDA Submissions

ORIG1AP1995-07-28
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1999-11-04
LABELING; LabelingSUPPL3AP1998-09-23
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-07-30
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2001-04-12

Submissions Property Types

SUPPL2Null0
SUPPL4Null0
SUPPL5Null0

TE Codes

001PrescriptionAN

CDER Filings

AM REGENT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72489
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETYLCYSTEINE","activeIngredients":"ACETYLCYSTEINE","strength":"10%","dosageForm":"SOLUTION;INHALATION, ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETYLCYSTEINE","submission":"ACETYLCYSTEINE","actionType":"10%","submissionClassification":"SOLUTION;INHALATION, ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.