PHARMACIA AND UPJOHN FDA Approval ANDA 060733

ANDA 060733

PHARMACIA AND UPJOHN

FDA Drug Application

Application #060733

Application Sponsors

ANDA 060733PHARMACIA AND UPJOHN

Marketing Status

Discontinued001
Prescription002

Application Products

001INJECTABLE;INJECTION10,000 UNITS/VIAL0BACITRACINBACITRACIN
002INJECTABLE;INJECTION50,000 UNITS/VIAL0BACITRACINBACITRACIN

FDA Submissions

ORIG1AP1948-07-29
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1991-02-20
LABELING; LabelingSUPPL6AP1994-04-08
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1995-03-10
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1996-09-16
LABELING; LabelingSUPPL9AP2004-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1999-12-02
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-04-05
LABELING; LabelingSUPPL12AP2004-05-05

Submissions Property Types

SUPPL5Null0
SUPPL7Null0
SUPPL8Null0
SUPPL10Null0
SUPPL11Null0

TE Codes

002PrescriptionAP

CDER Filings

PHARMACIA AND UPJOHN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 60733
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACITRACIN","activeIngredients":"BACITRACIN","strength":"10,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BACITRACIN","activeIngredients":"BACITRACIN","strength":"50,000 UNITS\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BACITRACIN","submission":"BACITRACIN","actionType":"10,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BACITRACIN","submission":"BACITRACIN","actionType":"50,000 UNITS\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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