TELIGENT PHARMA INC FDA Approval ANDA 074098

ANDA 074098

TELIGENT PHARMA INC

FDA Drug Application

Application #074098

Application Sponsors

ANDA 074098TELIGENT PHARMA INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 12.5MG BASE/ML0DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1995-02-21
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1997-09-15
LABELING; LabelingSUPPL3AP1998-02-18
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-09-22
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-10-30
LABELING; LabelingSUPPL7AP2002-10-22

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0

CDER Filings

TELIGENT PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74098
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOBUTAMINE HYDROCHLORIDE","activeIngredients":"DOBUTAMINE HYDROCHLORIDE","strength":"EQ 12.5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOBUTAMINE HYDROCHLORIDE","submission":"DOBUTAMINE HYDROCHLORIDE","actionType":"EQ 12.5MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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