CONTRACT PHARMACAL FDA Approval ANDA 071268

ANDA 071268

CONTRACT PHARMACAL

FDA Drug Application

Application #071268

Application Sponsors

ANDA 071268CONTRACT PHARMACAL

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL600MG0IBUPROFENIBUPROFEN
002TABLET;ORAL400MG0IBUPROFENIBUPROFEN
003TABLET;ORAL800MG0IBUPROFENIBUPROFEN

FDA Submissions

ORIG1AP1986-10-15
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1987-05-14
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1987-01-21
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1987-10-02
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1987-07-06
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1987-07-06
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1987-07-06
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1987-12-18
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1987-12-18
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1987-12-18
LABELING; LabelingSUPPL11AP1988-08-10
LABELING; LabelingSUPPL12AP1989-01-23
LABELING; LabelingSUPPL13AP2016-05-09STANDARD
LABELING; LabelingSUPPL14AP2019-07-22STANDARD
LABELING; LabelingSUPPL16AP2021-04-28STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL13Null7
SUPPL14Null15
SUPPL16Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

CONTRACT PHARMACAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71268
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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