WATSON LABS INC FDA Approval ANDA 062856

ANDA 062856

WATSON LABS INC

FDA Drug Application

Application #062856

Application Sponsors

ANDA 062856WATSON LABS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005

Application Products

001INJECTABLE;INJECTIONEQ 250MG BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM
002INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM
003INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM
004INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM
005INJECTABLE;INJECTIONEQ 4GM BASE/VIAL0OXACILLIN SODIUMOXACILLIN SODIUM

FDA Submissions

ORIG1AP1988-10-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1988-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1990-11-09
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1992-03-11
LABELING; LabelingSUPPL7AP1993-11-18
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1993-11-18
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1993-12-01
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1993-12-01
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1993-12-01
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1994-01-13
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1995-01-27
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1995-02-10
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1997-12-22
LABELING; LabelingSUPPL18AP1998-09-18
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1998-09-18
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1998-09-29
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1999-05-14
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2000-12-08

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0

CDER Filings

WATSON LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62856
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXACILLIN SODIUM","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 4GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXACILLIN SODIUM","submission":"OXACILLIN SODIUM","actionType":"EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXACILLIN SODIUM","submission":"OXACILLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXACILLIN SODIUM","submission":"OXACILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXACILLIN SODIUM","submission":"OXACILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXACILLIN SODIUM","submission":"OXACILLIN SODIUM","actionType":"EQ 4GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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