BAUSCH AND LOMB FDA Approval ANDA 074643

ANDA 074643

BAUSCH AND LOMB

FDA Drug Application

Application #074643

Application Sponsors

ANDA 074643BAUSCH AND LOMB

Marketing Status

Discontinued001

Application Products

001SOLUTION;TOPICAL2%0MINOXIDIL (FOR MEN)MINOXIDIL

FDA Submissions

ORIG1AP1996-04-09
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-10-18
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-04-07
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1998-03-27
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1999-04-29
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1999-08-11
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1999-08-11
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1999-08-11

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74643
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOXIDIL (FOR MEN)","activeIngredients":"MINOXIDIL","strength":"2%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MINOXIDIL (FOR MEN)","submission":"MINOXIDIL","actionType":"2%","submissionClassification":"SOLUTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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