UNICHEM FDA Approval ANDA 078989

ANDA 078989

UNICHEM

FDA Drug Application

Application #078989

Documents

Letter2008-06-10
Other Important Information from FDA2008-07-01

Application Sponsors

ANDA 078989UNICHEM

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL5MG0ZALEPLONZALEPLON
002CAPSULE;ORAL10MG0ZALEPLONZALEPLON

FDA Submissions

ORIG1AP2008-06-06
LABELING; LabelingSUPPL3AP2014-03-12STANDARD
LABELING; LabelingSUPPL9AP2019-10-03STANDARD
LABELING; LabelingSUPPL10AP2019-10-03STANDARD

Submissions Property Types

SUPPL3Null15
SUPPL9Null15
SUPPL10Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78989
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZALEPLON","activeIngredients":"ZALEPLON","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZALEPLON","activeIngredients":"ZALEPLON","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZALEPLON","submission":"ZALEPLON","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZALEPLON","submission":"ZALEPLON","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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