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    Approved Drug Products containing Azelastine Hydrochloride listed in the FDA Orange Book. Original Data : FDA Website

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    Azelastine Hydrochloride

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    01 AKORN (1)

    02 ALEMBIC (1)

    03 ALKEM LABS LTD (1)

    04 AMNEAL (2)

    05 AMNEAL PHARMS LLC (1)

    06 APOTEX (1)

    07 APOTEX INC (3)

    08 AUROBINDO PHARMA LTD (3)

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    01 SOLUTION/DROPS;OPHTHALMIC (8)

    02 SPRAY, METERED;NASAL (26)

    03 SPRAY;NASAL (2)

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    01 DISCN (11)

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    01 ASTELIN (1)

    02 ASTEPRO (4)

    03 ASTEPRO ALLERGY (1)

    04 AZELASTINE HYDROCHLORIDE (25)

    05 AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (2)

    06 CHILDRENS ASTEPRO ALLERGY (1)

    07 DYMISTA (1)

    08 OPTIVAR (1)

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    01 No (26)

    02 Yes (6)

    03 Blank (4)

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    APOTEX INC

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    AZELASTINE HYDROCHLORIDE

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    SPRAY, METERED;NASAL
    0.137MG/SPRAY
    2009-04-30
    77954
    AZELASTINE HYDROCHLORI...
    RX
    No
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    APOTEX INC

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    AZELASTINE HYDROCHLORIDE

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    SOLUTION/DROPS;OPHTHALMIC
    0.05%
    2009-08-03
    78621
    AZELASTINE HYDROCHLORI...
    RX
    No
    AT
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    BIONPHARMA

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      AZELASTINE HYDROCHLORIDE

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      SPRAY, METERED;NASAL
      0.137MG/SPRAY
      2015-07-28
      90176
      AZELASTINE HYDROCHLORI...
      RX
      No
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      MEDA PHARMS

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      SPRAY, METERED;NASAL
      0.1%
      22371
      ASTEPRO
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      MEDA PHARMS

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      AZELASTINE HYDROCHRLORIDE

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      SPRAY, METERED;NASAL
      0.15%
      22371
      ASTEPRO
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      SUN PHARM

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      AZELASTINE HYDROCHLORIDE

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      SOLUTION/DROPS;OPHTHALMIC
      0.05%
      2010-06-21
      78738
      AZELASTINE HYDROCHLORI...
      RX
      No
      AT
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      MYLAN SPCLT VIATRIS

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      AZELASTINE HYDROCHLORIDE

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      SPRAY, METERED;NASAL
      0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      1996-11-01
      20114
      ASTELIN
      DISCN
      Yes
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      MYLAN SPECIALITY LP

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      AZELASTINE HYDROCHLORIDE

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      SOLUTION/DROPS;OPHTHALMIC
      0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      2000-05-22
      21127
      OPTIVAR
      DISCN
      Yes
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      MYLAN SPECIALITY LP

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      AZELASTINE HYDROCHLORIDE

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      SPRAY, METERED;NASAL
      0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      2008-10-15
      22203
      ASTEPRO
      DISCN
      Yes
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      MYLAN SPECIALITY LP

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      AZELASTINE HYDROCHLORIDE

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      SPRAY, METERED;NASAL
      0.2055MG/SPRAY
      2009-08-31
      22203
      ASTEPRO
      DISCN
      No
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