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

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    Mayne Pharma
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    Country
    Australia
    Address
    Address
    1538 Main North Road, Salisbury South, SA 5106
    Telephone
    Telephone
    +61 8 8209 2666 
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    Email
    enquiries@pharmacompass.com
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    https://www.maynepharma.com/
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    • FDA
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    CALCIPOTRIENE

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    AEROSOL, FOAM; TOP...
    0.005%
    2010-10-06
    22563
    SORILUX
    RX
    Yes
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    • FDA
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    CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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    SOLUTION; ORAL
    4MG/5ML;5MG/5ML;60...
    2015-08-03
    205657
    HYDROCODONE BITART...
    DISCN
    No
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    DOXYCYCLINE HYCLATE

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    CAPSULE, DELAYED R...
    EQ 100MG BASE
    1985-07-22
    50582
    DORYX
    DISCN
    Yes
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    DOXYCYCLINE HYCLATE

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    CAPSULE, DELAYED R...
    EQ 75MG BASE
    2001-08-13
    50582
    DORYX
    DISCN
    Yes
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    DOXYCYCLINE HYCLATE

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    TABLET, DELAYED RE...
    EQ 75MG BASE
    2005-05-06
    50795
    DORYX
    DISCN
    Yes
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    DOXYCYCLINE HYCLATE

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    TABLET, DELAYED RE...
    EQ 100MG BASE
    2005-05-06
    50795
    DORYX
    DISCN
    Yes
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    DOXYCYCLINE HYCLATE

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    TABLET, DELAYED RE...
    EQ 150MG BASE
    2008-06-20
    50795
    DORYX
    DISCN
    Yes
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    DOXYCYCLINE HYCLATE

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    TABLET, DELAYED RE...
    EQ 80MG BASE
    2013-04-11
    50795
    DORYX
    RX
    Yes
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    DOXYCYCLINE HYCLATE

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    TABLET, DELAYED RE...
    EQ 200MG BASE
    2013-04-11
    50795
    DORYX
    RX
    Yes
    AB
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    DOXYCYCLINE HYCLATE

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    TABLET, DELAYED RE...
    EQ 50MG BASE
    2014-12-19
    50795
    DORYX
    DISCN
    Yes
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    DOXYCYCLINE HYCLATE

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    TABLET, DELAYED RE...
    EQ 60MG BASE
    2016-05-20
    50795
    DORYX MPC
    RX
    Yes
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    DOXYCYCLINE HYCLATE

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    TABLET, DELAYED RE...
    EQ 120MG BASE
    2016-05-20
    50795
    DORYX MPC
    DISCN
    Yes
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    • FDA
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    DROSPIRENONE; ESTETROL

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    TABLET; ORAL
    3MG;14.2MG
    2021-04-15
    214154
    NEXTSTELLIS
    RX
    Yes
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    ESTRADIOL

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    INSERT; VAGINAL
    0.004MG
    2018-05-29
    208564
    IMVEXXY
    RX
    Yes
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    ESTRADIOL

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    INSERT; VAGINAL
    0.01MG
    2018-05-29
    208564
    IMVEXXY
    RX
    Yes
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    ESTRADIOL; PROGESTERONE

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    CAPSULE; ORAL
    1MG;100MG
    2018-10-28
    210132
    BIJUVA
    RX
    Yes
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    ESTRADIOL; PROGESTERONE

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    CAPSULE; ORAL
    0.5MG;100MG
    2021-12-28
    210132
    BIJUVA
    RX
    Yes
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    ETHINYL ESTRADIOL; LEVONORGESTREL

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    TABLET; ORAL
    0.02MG,0.15MG;0.02...
    206201
    ETHINYL ESTRADIOL;...
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    ETHINYL ESTRADIOL; SEGESTERONE ACETATE

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    RING; VAGINAL
    0.013MG/24HR;0.15M...
    2018-08-10
    209627
    ANNOVERA
    RX
    Yes
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    FENTANYL

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    FILM, EXTENDED REL...
    25MCG/HR
    2007-08-20
    77062
    FENTANYL-25
    DISCN
    No
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    FENTANYL

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    FILM, EXTENDED REL...
    50MCG/HR
    2007-08-20
    77062
    FENTANYL-50
    DISCN
    No
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    FENTANYL

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    FILM, EXTENDED REL...
    75MCG/HR
    2007-08-20
    77062
    FENTANYL-75
    DISCN
    No
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    FENTANYL

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    FILM, EXTENDED REL...
    100MCG/HR
    2007-08-20
    77062
    FENTANYL-100
    DISCN
    No
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    • FDA
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    HALOBETASOL PROPIONATE

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    AEROSOL, FOAM; TOP...
    0.05%
    2018-05-24
    210566
    LEXETTE
    RX
    Yes
    AB
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    HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

    PDF Supplier PDF
    URL Supplier Web Content
    SOLUTION; ORAL
    5MG/5ML;60MG/5ML
    2015-11-17
    205658
    HYDROCODONE BITART...
    DISCN
    No
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    ITRACONAZOLE

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    CAPSULE; ORAL
    65MG
    2018-12-11
    208901
    TOLSURA
    RX
    Yes
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    OXYMETAZOLINE HYDROCHLORIDE

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    CREAM; TOPICAL
    1%
    2017-01-18
    208552
    RHOFADE
    RX
    Yes
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    TAMOXIFEN CITRATE

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    SOLUTION; ORAL
    EQ 20MG BASE/10ML
    2005-10-29
    21807
    SOLTAMOX
    RX
    Yes
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    TAZAROTENE

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    AEROSOL, FOAM; TOP...
    0.1%
    2012-05-11
    202428
    FABIOR
    RX
    Yes
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