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    Approved Drug Products of Tris Pharma Inc listed in the FDA Orange Book. Original Data : FDA Website

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    TRIS PHARMA INC

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    Tris Pharma Inc
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    Brunswick Business Park, 2033 Route 130, Suite D, Monmouth Junction, NJ 08852,
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    (732) 940-2800
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    • FDA
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    SOLUTION; ORAL
    325MG/15ML;7.5MG/1...
    2021-12-30
    201295
    HYDROCODONE BITART...
    DISCN
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    SOLUTION; ORAL
    300MG/15ML;10MG/15...
    2021-12-30
    201295
    HYDROCODONE BITART...
    DISCN
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;5MG
    2013-03-27
    202214
    HYDROCODONE BITART...
    RX
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;7.5MG
    2013-03-27
    202214
    HYDROCODONE BITART...
    RX
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;10MG
    2013-03-27
    202214
    HYDROCODONE BITART...
    RX
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    300MG;5MG
    2016-03-15
    202214
    HYDROCODONE BITART...
    RX
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    300MG;7.5MG
    2016-03-15
    202214
    HYDROCODONE BITART...
    RX
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    300MG;10MG
    2016-03-15
    202214
    HYDROCODONE BITART...
    RX
    No
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    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

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    SUSPENSION, EXTEND...
    2MG/ML;EQ 0.5MG BA...
    2015-10-19
    208147
    DYANAVEL XR
    RX
    Yes
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    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

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    TABLET, EXTENDED R...
    4MG;EQ 1MG BASE
    2021-11-04
    210526
    DYANAVEL XR 5
    RX
    Yes
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    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

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    TABLET, EXTENDED R...
    8MG;EQ 2MG BASE
    2021-11-04
    210526
    DYANAVEL XR 10
    RX
    Yes
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    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

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    TABLET, EXTENDED R...
    12MG;EQ 3MG BASE
    2021-11-04
    210526
    DYANAVEL XR 15
    RX
    Yes
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    AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE

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    TABLET, EXTENDED R...
    16MG;EQ 4MG BASE
    2021-11-04
    210526
    DYANAVEL XR 20
    RX
    Yes
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    • FDA
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    CETIRIZINE HYDROCHLORIDE

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    SOLUTION; ORAL
    5MG/5ML
    2012-11-16
    90572
    CHILDRENS CETIRIZI...
    DISCN
    No
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    CETIRIZINE HYDROCHLORIDE

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    SOLUTION; ORAL
    5MG/5ML
    2012-11-16
    90572
    CHILDRENS CETIRIZI...
    DISCN
    No
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    CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE

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    SOLUTION; ORAL
    4MG/5ML;5MG/5ML
    2015-01-27
    206438
    HYDROCODONE BITART...
    DISCN
    No
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    CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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    SOLUTION; ORAL
    4MG/5ML;5MG/5ML;60...
    2014-11-26
    203838
    HYDROCODONE BITART...
    DISCN
    No
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    CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX

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    SUSPENSION, EXTEND...
    EQ 2.8MG BASE/5ML;...
    2015-04-30
    207768
    TUZISTRA XR
    DISCN
    Yes
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    CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX

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    SUSPENSION, EXTEND...
    EQ 8MG MALEATE/5ML...
    2010-10-01
    91632
    HYDROCODONE POLIST...
    RX
    No
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    CLONIDINE

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    SUSPENSION, EXTEND...
    EQ 0.09MG BASE/ML
    2009-12-03
    22499
    CLONIDINE
    DISCN
    No
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    CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

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    SYRUP; ORAL
    10MG/5ML;6.25MG/5M...
    2012-06-29
    200386
    PROMETHAZINE HYDRO...
    RX
    No
    AA
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    CYPROHEPTADINE HYDROCHLORIDE

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    SYRUP; ORAL
    2MG/5ML
    2021-12-21
    205431
    CYPROHEPTADINE HYD...
    DISCN
    No
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    DEXMETHYLPHENIDATE HYDROCHLORIDE

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    TABLET; ORAL
    2.5MG
    2016-08-26
    207901
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
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    DEXMETHYLPHENIDATE HYDROCHLORIDE

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    TABLET; ORAL
    5MG
    2016-08-26
    207901
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
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    DEXMETHYLPHENIDATE HYDROCHLORIDE

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    TABLET; ORAL
    10MG
    2016-08-26
    207901
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
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    DEXTROAMPHETAMINE SULFATE

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    SOLUTION; ORAL
    5MG/5ML
    2013-05-29
    203644
    DEXTROAMPHETAMINE ...
    RX
    No
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    DEXTROAMPHETAMINE SULFATE

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    TABLET; ORAL
    5MG
    2022-08-18
    206095
    DEXTROAMPHETAMINE ...
    DISCN
    No
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    DEXTROAMPHETAMINE SULFATE

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    TABLET; ORAL
    10MG
    2022-08-18
    206095
    DEXTROAMPHETAMINE ...
    DISCN
    No
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    DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

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    SYRUP; ORAL
    15MG/5ML;6.25MG/5M...
    2012-06-28
    91687
    PROMETHAZINE HYDRO...
    RX
    No
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    DEXTROMETHORPHAN POLISTIREX

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    SUSPENSION, EXTEND...
    EQ 30MG HYDROBROMI...
    2012-05-25
    91135
    DEXTROMETHORPHAN P...
    OTC
    No
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    HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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    SOLUTION; ORAL
    5MG/5ML;60MG/5ML
    2014-10-28
    203839
    HYDROCODONE BITART...
    DISCN
    No
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    IBUPROFEN

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    SUSPENSION/DROPS; ...
    40MG/ML
    2009-08-31
    79058
    IBUPROFEN
    OTC
    No
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    METHYLPHENIDATE HYDROCHLORIDE

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    SOLUTION; ORAL
    5MG/5ML
    2010-07-23
    91601
    METHYLPHENIDATE HY...
    RX
    No
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    METHYLPHENIDATE HYDROCHLORIDE

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    SOLUTION; ORAL
    10MG/5ML
    2010-07-23
    91601
    METHYLPHENIDATE HY...
    RX
    No
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    MORPHINE SULFATE

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    SOLUTION; ORAL
    10MG/5ML
    2015-05-12
    203518
    MORPHINE SULFATE
    RX
    No
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    MORPHINE SULFATE

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    SOLUTION; ORAL
    100MG/5ML
    2015-05-12
    203518
    MORPHINE SULFATE
    RX
    No
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    MORPHINE SULFATE

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    SOLUTION; ORAL
    20MG/5ML
    2016-05-18
    203519
    MORPHINE SULFATE
    DISCN
    No
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    POTASSIUM CHLORIDE

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    CAPSULE, EXTENDED ...
    8MEQ
    2016-03-04
    201944
    POTASSIUM CHLORIDE
    DISCN
    No
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    POTASSIUM CHLORIDE

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    CAPSULE, EXTENDED ...
    10MEQ
    2016-03-04
    201944
    POTASSIUM CHLORIDE
    DISCN
    No
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    POTASSIUM CHLORIDE

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    SOLUTION; ORAL
    20MEQ/15ML
    2022-01-26
    214076
    POTASSIUM CHLORIDE
    DISCN
    No
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    POTASSIUM CHLORIDE

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    SOLUTION; ORAL
    40MEQ/15ML
    2022-01-26
    214076
    POTASSIUM CHLORIDE
    DISCN
    No
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    PROMETHAZINE HYDROCHLORIDE

    PDF Supplier PDF
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    SYRUP; ORAL
    6.25MG/5ML
    2012-06-28
    91675
    PROMETHAZINE HYDRO...
    RX
    No
    AA
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    PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE

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    TABLET, CHEWABLE, ...
    15MG/5ML
    91687
    PROMETHAZINE HYDRO...
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    RISPERIDONE

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    SOLUTION; ORAL
    1MG/ML
    2012-12-12
    79059
    RISPERIDONE
    RX
    No
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    SILDENAFIL CITRATE

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    FOR SUSPENSION; OR...
    EQ 10MG BASE/ML
    2021-11-17
    212312
    SILDENAFIL CITRATE
    DISCN
    No
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    THEOPHYLLINE

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    SOLUTION; ORAL
    80MG/15ML
    2012-06-15
    91586
    THEOPHYLLINE
    RX
    No
    AA
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