PLIVA FDA Approval ANDA 072317

ANDA 072317

PLIVA

FDA Drug Application

Application #072317

Application Sponsors

ANDA 072317PLIVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORALEQ 4MG BASE0ALBUTEROL SULFATEALBUTEROL SULFATE

FDA Submissions

ORIG1AP1989-01-30
LABELING; LabelingSUPPL2AP1992-06-04
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1994-05-11
LABELING; LabelingSUPPL4AP1994-05-17
LABELING; LabelingSUPPL5AP1994-05-17
LABELING; LabelingSUPPL6AP1995-12-22
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1996-03-05
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1996-08-01
LABELING; LabelingSUPPL9AP1998-05-20
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-07-07

Submissions Property Types

SUPPL3Null0
SUPPL7Null0
SUPPL8Null0
SUPPL10Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72317
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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