WATSON LABS INC FDA Approval ANDA 062984

ANDA 062984

WATSON LABS INC

FDA Drug Application

Application #062984

Application Sponsors

ANDA 062984WATSON LABS INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 10GM BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM

FDA Submissions

ORIG1AP1988-09-29
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1990-11-09
LABELING; LabelingSUPPL3AP1994-03-18
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1992-03-11
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1993-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1994-01-13
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1995-01-27
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1995-02-10
LABELING; LabelingSUPPL11AP1997-07-22
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1997-12-22
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1998-09-29
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1999-05-14
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2000-12-08
LABELING; LabelingSUPPL17AP2016-04-04STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null15

CDER Filings

WATSON LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62984
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXACILLIN SODIUM","submission":"OXACILLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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