ACME LABS FDA Approval ANDA 077214

ANDA 077214

ACME LABS

FDA Drug Application

Application #077214

Documents

Letter2007-05-01

Application Sponsors

ANDA 077214ACME LABS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
002TABLET;ORAL10MG0ZOLPIDEM TARTRATEZOLPIDEM TARTRATE

FDA Submissions

ORIG1AP2007-04-23
LABELING; LabelingSUPPL2AP2008-09-03
LABELING; LabelingSUPPL3AP2010-08-16
LABELING; LabelingSUPPL5AP2013-09-18STANDARD
LABELING; LabelingSUPPL6AP2015-06-01STANDARD
LABELING; LabelingSUPPL8AP2022-11-17STANDARD

Submissions Property Types

SUPPL5Null15
SUPPL6Null7
SUPPL8Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ACME LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77214
            [companyName] => ACME LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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