STI PHARMA LLC FDA Approval ANDA 088704

ANDA 088704

STI PHARMA LLC

FDA Drug Application

Application #088704

Documents

Other2018-05-01

Application Sponsors

ANDA 088704STI PHARMA LLC

Marketing Status

Prescription001

Application Products

001SYRUP;ORAL10MG/5ML;30MG/5ML;1.25MG/5ML0TRIACIN-CCODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1985-03-22
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1985-12-06
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1986-12-11
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1986-12-11
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1987-03-17
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1989-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1989-06-07
LABELING; LabelingSUPPL10AP1990-05-01
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1992-06-05
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1990-09-28
LABELING; LabelingSUPPL13AP1992-09-11
LABELING; LabelingSUPPL16AP1992-01-08
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1994-06-06
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1995-03-31
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1998-08-19
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2000-10-02
LABELING; LabelingSUPPL33AP2015-07-08STANDARD
LABELING; LabelingSUPPL34AP2017-01-13STANDARD
LABELING; LabelingSUPPL35AP2017-03-15STANDARD
LABELING; LabelingSUPPL36AP2017-03-15STANDARD
LABELING; LabelingSUPPL37AP2017-08-29STANDARD
LABELING; LabelingSUPPL38AP2018-06-28STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL11Null0
SUPPL12Null0
SUPPL17Null0
SUPPL18Null0
SUPPL20Null0
SUPPL21Null0
SUPPL33Null7
SUPPL34Null7
SUPPL35Null7
SUPPL36Null15
SUPPL37Null15
SUPPL38Null7

CDER Filings

STI PHARMA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88704
            [companyName] => STI PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIACIN-C","activeIngredients":"CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE","strength":"10MG\/5ML;30MG\/5ML;1.25MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIACIN-C","submission":"CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE","actionType":"10MG\/5ML;30MG\/5ML;1.25MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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