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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Janssen Pharmaceutical to the Review Authority in Korea.

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    Janssen Pharmaceutical
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    Country
    U.S.A
    Address
    Address
    1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, NJ 08560
    Telephone
    Telephone
    +1-800-775-5514.
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    enquiries@pharmacompass.com
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    https://www.janssen.com/us/
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    • FDA
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    Abiraterone Acetate

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    Janssen Korea Co., Ltd.
    2015-06-04
    CAN 4945-22-ND
    Janssen Pharmaceutica NV
    Belgium
    Janssen Pharmaceuticalaan...
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    Dapoxetine Hydrochloride

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    Menarini Korea Co., Ltd.
    2008-08-29
    Wed 217-4-ND
    Janssen Pharmaceutica NV
    U.S.A
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    Darunavir ethanolate

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    Janssen Korea Co., Ltd.
    2009-07-20
    Wed-217-10-ND
    Janssen Pharmaceutical Sc...
    U.S.A
    Little Island Industrial ...
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    domperidone maleate

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    Janssen Korea Co., Ltd.
    2005-09-30
    20050930-11-B-217-03
    Janssen Pharmaceutical
    U.S.A
    Little Island Industrial ...
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    domperidone maleate

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    Janssen Korea Co., Ltd.
    2008-05-29
    20080530-11-B-276-05
    Janssen Pharmaceutica NV
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    Etravirine

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    Janssen Korea Co., Ltd.
    2008-05-07
    Wed 217-3-ND
    Janssen Pharmaceutica NV
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    Flunarizine hydrochloride

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    Janssen Korea Co., Ltd.
    2021-09-02
    20210902-209-J-1103
    Janssen Pharmaceutical Sc...
    Ireland
    Little Island Industrial ...
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    Galantamine hydrobromide

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    Janssen Korea Co., Ltd.
    2021-06-10
    20210610-209-J-538
    Janssen Pharmaceutica NV
    Belgium
    Jassen Pharmaceuticalaan ...
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    Itraconazole

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    Janssen Korea Co., Ltd.
    2005-08-31
    20050831-56-A-104-05
    Janssen Pharmaceutical Sc...
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    Little Island Industrial ...
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    Itraconazole

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    Janssen Korea Co., Ltd.
    2005-08-31
    20050831-56-A-103-04
    Janssen Pharmaceutica NV
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    Itraconazole

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    Janssen Korea Co., Ltd.
    2005-08-31
    20050831-56-A-102-03
    Janssen Pharmaceutica NV
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    Ketoconazole

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    Huons Co., Ltd.
    2012-08-14
    20120814-167-I-49-02
    Janssen Pharmaceutica NV
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    methylphenidate hydrochloride

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    Janssen Korea Co., Ltd.
    2020-07-15
    20200715-209-J-691
    Janssen Pharmaceuticals, ...
    U.S.A
    1440 Olympic Drive, Athen...
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    Nebivolol Hydrochloride

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    Menarini Korea Co., Ltd.
    2012-10-12
    20121012-178-I-128-03
    Janssen Pharmaceutica NV
    U.S.A
    Jassen Pharmaceuticalaan ...
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    Paliperidone

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    Janssen Korea Co., Ltd.
    2007-08-31
    Wed 217-2-ND
    Janssen Pharmaceutical Sc...
    U.S.A
    Little Island, Co. Cork, ...
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    Paliperidone Palmitate

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    Janssen Korea Co., Ltd.
    2010-05-27
    Wed 217-12-ND
    Janssen Pharmaceutica NV
    U.S.A
    Turnhoutseweg 30, B-2340 ...
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    Paliperidone Palmitate

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    Janssen Korea Co., Ltd.
    2011-09-16
    Wed 217-13-ND
    Janssen Pharmaceutical Sc...
    U.S.A
    Little Island Industrial ...
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    prucalopride succinate

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    Menarini Korea Co., Ltd.
    2012-10-26
    Wed 217-15-ND
    Janssen Pharmaceutica NV
    U.S.A
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    Rilpivirine hydrochloride

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    Janssen Korea Co., Ltd.
    2011-10-28
    Wed 217-14-ND
    Janssen Pharmaceutical Sc...
    U.S.A
    Little Island Industrial ...
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    Risperidone

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    Janssen Korea Co., Ltd.
    2005-08-31
    20050831-10-C-82-06
    Janssen Pharmaceutical Sc...
    U.S.A
    Little Island Industrial ...
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    Risperidone

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    Janssen Korea Co., Ltd.
    2005-08-31
    20050831-10-C-81-05
    Janssen Pharmaceutica NV
    U.S.A
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    topiramate

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    Janssen Korea Co., Ltd.
    2012-09-07
    20120907-170-I-44-03
    Janssen Pharmaceuticals I...
    U.S.A
    1440 Olympic Drive, Athen...
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    Aspalutamide

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    Janssen Korea Co., Ltd.
    2020-12-29
    Su81-24-ND
    Janssen Pharmaceuticals, ...
    U.S.A
    1440 Olympic Drive, Athen...
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