ZYDUS PHARMS USA INC FDA Approval ANDA 090460

ANDA 090460

ZYDUS PHARMS USA INC

FDA Drug Application

Application #090460

Application Sponsors

ANDA 090460ZYDUS PHARMS USA INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL325MG;37.5MG0TRAMADOL HYDROCHLORIDE AND ACETAMINOPHENACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

FDA Submissions

ORIG1AP2012-09-06
LABELING; LabelingSUPPL2AP2014-08-01STANDARD
LABELING; LabelingSUPPL3AP2016-06-20STANDARD
LABELING; LabelingSUPPL6AP2017-03-23STANDARD
REMS; REMSSUPPL9AP2018-09-18

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL3Null15
SUPPL6Null7
SUPPL9Null15

TE Codes

001PrescriptionAB

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90460
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","strength":"325MG;37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE","actionType":"325MG;37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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