STORZ FDA Approval NDA 050268

NDA 050268

STORZ

FDA Drug Application

Application #050268

Application Sponsors

NDA 050268STORZ

Marketing Status

Discontinued001

Application Products

001SUSPENSION/DROPS;OPHTHALMIC1%0ACHROMYCINTETRACYCLINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP1955-11-23UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1983-03-22
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1983-06-21
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1983-06-21
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1985-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1986-05-23
LABELING; LabelingSUPPL7AP1961-03-17
LABELING; LabelingSUPPL8AP1986-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1962-02-20
LABELING; LabelingSUPPL10AP1961-10-30
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1991-06-28
LABELING; LabelingSUPPL13AP1962-02-20
LABELING; LabelingSUPPL14AP1963-05-01
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1965-03-25
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1965-10-20
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1968-11-05
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1970-06-12
LABELING; LabelingSUPPL19AP1972-07-28
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1974-01-09
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1974-05-06
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1974-08-28
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1975-06-13
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1975-04-25
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1975-10-06
LABELING; LabelingSUPPL26AP1975-12-29
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1981-03-20
LABELING; LabelingSUPPL28AP1981-07-24
MANUF (CMC); Manufacturing (CMC)SUPPL29AP1982-03-23
MANUF (CMC); Manufacturing (CMC)SUPPL30AP1988-12-01

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL9Null0
SUPPL11Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL27Null0
SUPPL29Null0
SUPPL30Null0

CDER Filings

STORZ
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50268
            [companyName] => STORZ
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACHROMYCIN","activeIngredients":"TETRACYCLINE HYDROCHLORIDE","strength":"1%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACHROMYCIN","submission":"TETRACYCLINE HYDROCHLORIDE","actionType":"1%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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