NESHER PHARMS FDA Approval ANDA 070980

ANDA 070980

NESHER PHARMS

FDA Drug Application

Application #070980

Application Sponsors

ANDA 070980NESHER PHARMS

Marketing Status

Discontinued001

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL10MEQ0POTASSIUM CHLORIDEPOTASSIUM CHLORIDE

FDA Submissions

ORIG1AP1987-02-17
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1989-12-22
LABELING; LabelingSUPPL3AP1989-12-22
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1990-05-25
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1991-12-06
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1991-02-15
LABELING; LabelingSUPPL8AP1991-02-28
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1992-02-28
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1992-02-28
LABELING; LabelingSUPPL11AP1992-02-28
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1992-12-22
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1992-08-19
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1993-04-16
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1998-06-30
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1999-03-04
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2000-11-30
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2000-11-30
LABELING; LabelingSUPPL21AP2000-11-30
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2000-09-25
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2002-03-13

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL26Null0

CDER Filings

NESHER PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70980
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"POTASSIUM CHLORIDE","activeIngredients":"POTASSIUM CHLORIDE","strength":"10MEQ","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"POTASSIUM CHLORIDE","submission":"POTASSIUM CHLORIDE","actionType":"10MEQ","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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