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    Approved Drug Products of Novel Laboratories, Inc. listed in the FDA Orange Book. Original Data : FDA Website

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    NOVEL LABORATORIES, INC.

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    Novel Laboratories, Inc.
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    Country
    Country
    U.S.A
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    Address
    400 Campus Drive, Somerset, NJ 08873 
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    (908) 603-6000
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    enquiries@pharmacompass.com
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    http://www.novellabs.net/
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    • FDA
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    300MG;5MG
    2016-11-14
    206142
    HYDROCODONE BITART...
    DISCN
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    300MG;7.5MG
    2016-11-14
    206142
    HYDROCODONE BITART...
    DISCN
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    300MG;10MG
    2016-11-14
    206142
    HYDROCODONE BITART...
    DISCN
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;5MG
    2016-12-01
    206245
    HYDROCODONE BITART...
    DISCN
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;7.5MG
    2016-12-01
    206245
    HYDROCODONE BITART...
    DISCN
    No
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    ACETAMINOPHEN; HYDROCODONE BITARTRATE

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    TABLET; ORAL
    325MG;10MG
    2016-12-01
    206245
    HYDROCODONE BITART...
    DISCN
    No
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    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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    TABLET; ORAL
    325MG;2.5MG
    2017-02-24
    204407
    OXYCODONE AND ACET...
    RX
    No
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    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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    TABLET; ORAL
    325MG;5MG
    2017-02-24
    204407
    OXYCODONE AND ACET...
    RX
    No
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    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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    TABLET; ORAL
    325MG;7.5MG
    2017-02-24
    204407
    OXYCODONE AND ACET...
    RX
    No
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    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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    TABLET; ORAL
    325MG;10MG
    2017-02-24
    204407
    OXYCODONE AND ACET...
    RX
    No
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    AMLODIPINE BESYLATE; VALSARTAN

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    TABLET; ORAL
    EQ 5MG BASE;160MG
    2015-03-30
    202829
    AMLODIPINE BESYLAT...
    RX
    No
    AB
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    AMLODIPINE BESYLATE; VALSARTAN

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    TABLET; ORAL
    EQ 10MG BASE;160MG
    2015-03-30
    202829
    AMLODIPINE BESYLAT...
    RX
    No
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    AMLODIPINE BESYLATE; VALSARTAN

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    TABLET; ORAL
    EQ 5MG BASE;320MG
    2015-03-30
    202829
    AMLODIPINE BESYLAT...
    RX
    No
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    AMLODIPINE BESYLATE; VALSARTAN

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    TABLET; ORAL
    EQ 10MG BASE;320MG
    2015-03-30
    202829
    AMLODIPINE BESYLAT...
    RX
    No
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    • FDA
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    ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

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    FOR SOLUTION; ORAL
    4.7GM;100GM;1.015G...
    2012-01-25
    90145
    PEG-3350, SODIUM S...
    RX
    No
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    AZITHROMYCIN

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    FOR SUSPENSION; OR...
    EQ 100MG BASE/5ML
    202793
    AZITHROMYCIN
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    AZITHROMYCIN

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    FOR SUSPENSION; OR...
    EQ 200MG BASE/5ML
    202793
    AZITHROMYCIN
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    BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

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    FOR SOLUTION, TABL...
    5MG,N/A;N/A,210GM;...
    2014-08-20
    202217
    PEG-3350, SODIUM C...
    DISCN
    No
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    CARBIDOPA

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    TABLET; ORAL
    25MG
    2017-10-20
    204763
    CARBIDOPA
    RX
    No
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    CETIRIZINE HYDROCHLORIDE

    PDF Supplier PDF
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    TABLET, CHEWABLE; ...
    5MG
    2016-03-08
    206793
    CHILDRENS CETIRIZI...
    OTC
    No
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    CETIRIZINE HYDROCHLORIDE

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    TABLET, CHEWABLE; ...
    10MG
    2016-03-08
    206793
    CHILDRENS CETIRIZI...
    OTC
    No
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    CEVIMELINE HYDROCHLORIDE

    PDF Supplier PDF
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    CAPSULE; ORAL
    30MG
    2016-12-30
    204746
    CEVIMELINE HYDROCH...
    RX
    No
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    CLOBETASOL PROPIONATE

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    SOLUTION; TOPICAL
    0.05%
    2015-11-23
    206075
    CLOBETASOL PROPION...
    RX
    No
    AT
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    CLOBETASOL PROPIONATE

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    OINTMENT; TOPICAL
    0.05%
    2018-05-04
    208841
    CLOBETASOL PROPION...
    RX
    No
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    DESOXIMETASONE

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    OINTMENT; TOPICAL
    0.25%
    2016-05-10
    206792
    DESOXIMETASONE
    RX
    No
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    • FDA
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    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    2.5MG
    2015-12-04
    204534
    DEXMETHYLPHENIDATE...
    RX
    No
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    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    5MG
    2015-12-04
    204534
    DEXMETHYLPHENIDATE...
    RX
    No
    AB
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    DEXMETHYLPHENIDATE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    TABLET; ORAL
    10MG
    2015-12-04
    204534
    DEXMETHYLPHENIDATE...
    RX
    No
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    DEXTROAMPHETAMINE SULFATE

    PDF Supplier PDF
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    TABLET; ORAL
    5MG
    2016-03-16
    204330
    DEXTROAMPHETAMINE ...
    RX
    No
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    DEXTROAMPHETAMINE SULFATE

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    TABLET; ORAL
    10MG
    2016-03-16
    204330
    DEXTROAMPHETAMINE ...
    RX
    No
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    DIAZEPAM

    PDF Supplier PDF
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    GEL; RECTAL
    10MG/2ML (5MG/ML)
    2023-05-30
    91076
    DIAZEPAM
    RX
    No
    AB
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    DIAZEPAM

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    GEL; RECTAL
    20MG/4ML (5MG/ML)
    2023-05-30
    91076
    DIAZEPAM
    RX
    No
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    DICLOFENAC SODIUM

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    SOLUTION; TOPICAL
    1.5%
    2015-12-09
    205878
    DICLOFENAC SODIUM
    RX
    No
    AT
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    DOXYCYCLINE HYCLATE

    PDF Supplier PDF
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    TABLET; ORAL
    EQ 100MG BASE
    2017-09-06
    207558
    DOXYCYCLINE HYCLAT...
    RX
    No
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    FAMOTIDINE

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    FOR SUSPENSION; OR...
    40MG/5ML
    2012-12-17
    201695
    FAMOTIDINE
    RX
    No
    AB
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    FLUCYTOSINE

    PDF Supplier PDF
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    CAPSULE; ORAL
    250MG
    2017-07-07
    204652
    FLUCYTOSINE
    RX
    No
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    FLUCYTOSINE

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    CAPSULE; ORAL
    500MG
    2017-07-07
    204652
    FLUCYTOSINE
    RX
    No
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    FLUOCINOLONE ACETONIDE

    PDF Supplier PDF
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    OIL; TOPICAL
    0.01%
    2023-07-31
    207345
    FLUOCINOLONE ACETO...
    RX
    No
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    FLUOCINOLONE ACETONIDE

    PDF Supplier PDF
    URL Supplier Web Content
    OIL; TOPICAL
    0.01%
    2023-08-07
    207347
    FLUOCINOLONE ACETO...
    RX
    No
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    FLUOCINONIDE

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    SOLUTION; TOPICAL
    0.05%
    2017-07-21
    206003
    FLUOCINONIDE
    RX
    No
    AT
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    HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

    PDF Supplier PDF
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    TABLET; ORAL
    1.5MG;5MG
    2011-04-20
    91528
    HOMATROPINE METHYL...
    DISCN
    No
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    HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

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    SYRUP; ORAL
    1.5MG/5ML;5MG/5ML
    2017-02-13
    203535
    HYDROCODONE BITART...
    RX
    No
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    LEVONORGESTREL

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    TABLET; ORAL
    1.5MG
    2013-02-22
    202508
    LEVONORGESTREL
    OTC
    No
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    LINEZOLID

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    TABLET; ORAL
    600MG
    2016-08-22
    207526
    LINEZOLID
    RX
    No
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    MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

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    SOLUTION; ORAL
    1.6GM/BOT;3.13GM/B...
    2017-02-23
    202511
    SODIUM SULFATE, PO...
    RX
    No
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    METHYLPHENIDATE HYDROCHLORIDE

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    TABLET, CHEWABLE; ...
    2.5MG
    2015-02-25
    204115
    METHYLPHENIDATE HY...
    DISCN
    No
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    METHYLPHENIDATE HYDROCHLORIDE

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    TABLET, CHEWABLE; ...
    5MG
    2015-02-25
    204115
    METHYLPHENIDATE HY...
    DISCN
    No
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    METHYLPHENIDATE HYDROCHLORIDE

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    TABLET; ORAL
    5MG
    2015-11-13
    207884
    METHYLPHENIDATE HY...
    RX
    No
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    METHYLPHENIDATE HYDROCHLORIDE

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    TABLET; ORAL
    10MG
    2015-11-13
    207884
    METHYLPHENIDATE HY...
    RX
    No
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    METHYLPHENIDATE HYDROCHLORIDE

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    TABLET; ORAL
    20MG
    2015-11-13
    207884
    METHYLPHENIDATE HY...
    RX
    No
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