WATSON LABS INC FDA Approval ANDA 062816

ANDA 062816

WATSON LABS INC

FDA Drug Application

Application #062816

Application Sponsors

ANDA 062816WATSON LABS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005

Application Products

001INJECTABLE;INJECTIONEQ 125MG BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM
002INJECTABLE;INJECTIONEQ 250MG BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM
003INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM
004INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM
005INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0AMPICILLIN SODIUMAMPICILLIN SODIUM

FDA Submissions

ORIG1AP1988-10-28
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1988-11-10
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1988-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1991-01-23
LABELING; LabelingSUPPL9AP1990-12-26
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1993-11-09
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1993-11-09
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1993-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1994-01-13
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1995-01-27
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1995-06-23
LABELING; LabelingSUPPL17AP1996-03-12
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1996-04-17
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1997-07-30
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1997-12-29
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1999-11-08
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2000-12-08

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0

CDER Filings

WATSON LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62816
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 125MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN SODIUM","activeIngredients":"AMPICILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 125MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN SODIUM","submission":"AMPICILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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