TELIGENT PHARMA INC FDA Approval ANDA 063293

ANDA 063293

TELIGENT PHARMA INC

FDA Drug Application

Application #063293

Application Sponsors

ANDA 063293TELIGENT PHARMA INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0CEFOTANCEFOTETAN DISODIUM
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0CEFOTANCEFOTETAN DISODIUM

FDA Submissions

ORIG1AP1993-04-29
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1994-10-11
LABELING; LabelingSUPPL4AP1996-08-06

Submissions Property Types

ORIG1Null0
SUPPL3Null0
SUPPL4Null0

CDER Filings

TELIGENT PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 63293
            [companyName] => TELIGENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFOTAN","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFOTAN","activeIngredients":"CEFOTETAN DISODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFOTAN","submission":"CEFOTETAN DISODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFOTAN","submission":"CEFOTETAN DISODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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