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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Shandong Xinhua Pharmaceutical

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    Shandong Xinhua Pharmaceutical
    China Flag
    Country
    Country
    China
    Address
    Address
    No. 1 Lutai Avenue, Zibo High-tech Zone, Shandong Province
    Telephone
    Telephone
    +86-533- 2196803
    Client Email
    Email
    enquiries@pharmacompass.com
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    Website
    http://xhzy.com/html/english/default.aspx
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    • FDA
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    Caffeine

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    USDMF

    Found USDMF

    13092
    Active
    CAFFEINE ANHYDROUS
    1998-07-10
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-027 - Rev 03
    Valid
    Caffeine
    2015-08-24
    Japanese DMF

    Found JDMF

    301MF10007
    Japanese Pharmacopoeia Anhydrous Ca...
    2019-05-27
    Written Confirmation

    Close WC

    Application Number
    13092
    R1-CEP 2003-027 - Rev 03
    301MF10007
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CAFFEINE ANHYDROUS
    Caffeine
    Japanese Pharmacopoeia Anhydrous Ca...
    Issue/Submission Date
    1998-07-10
    2015-08-24
    2019-05-27
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    • FDA
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    Carbidopa

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    USDMF

    Found USDMF

    27430
    Active
    CARBIDOPA
    2013-07-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-052 - Rev 00
    Valid
    Carbidopa
    2022-04-20
    Japanese DMF

    Found JDMF

    227MF10242
    Japanese Pharmacopoeia carbidopa hy...
    2015-10-07
    Written Confirmation

    Close WC

    Application Number
    27430
    R1-CEP 2016-052 - Rev 00
    227MF10242
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CARBIDOPA
    Carbidopa
    Japanese Pharmacopoeia carbidopa hy...
    Issue/Submission Date
    2013-07-23
    2022-04-20
    2015-10-07
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    • FDA
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    Etilevodopa

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    USDMF

    Found USDMF

    22598
    Active
    LEVODOPA
    2009-03-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-174 - Rev 02
    Valid
    Levodopa
    2022-04-11
    Japanese DMF

    Found JDMF

    221MF10029
    Japanese Pharmacopoeia levodopa (pr...
    2009-02-09
    Written Confirmation

    Close WC

    Application Number
    22598
    R1-CEP 2009-174 - Rev 02
    221MF10029
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LEVODOPA
    Levodopa
    Japanese Pharmacopoeia levodopa (pr...
    Issue/Submission Date
    2009-03-05
    2022-04-11
    2009-02-09
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    • FDA
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    Theophylline

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    USDMF

    Found USDMF

    4633
    Active
    THEOPHYLLINE
    1982-07-28
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-004 - Rev 07
    Valid
    Theophylline
    2017-02-02
    Japanese DMF

    Found JDMF

    217MF10482
    Japanese Pharmacopoeia theophylline...
    2005-09-06
    Written Confirmation

    Close WC

    Application Number
    4633
    R1-CEP 1998-004 - Rev 07
    217MF10482
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    THEOPHYLLINE
    Theophylline
    Japanese Pharmacopoeia theophylline...
    Issue/Submission Date
    1982-07-28
    2017-02-02
    2005-09-06
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    • FDA
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    Aspirin

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    USDMF

    Found USDMF

    10730
    Active
    ASPIRIN
    1994-01-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-210 - Rev 05
    Valid
    Acetylsalicylic acid
    2016-11-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10730
    R1-CEP 2001-210 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ASPIRIN
    Acetylsalicylic acid
    Issue/Submission Date
    1994-01-20
    2016-11-14
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    • FDA
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    Glimepiride

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    USDMF

    Found USDMF

    32319
    Active
    GLIMEPIRIDE
    2017-11-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10169
    Glimepiride at No. 1, Lutai Road, H...
    2021-11-25
    Written Confirmation

    Close WC

    Application Number
    32319
    303MF10169
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GLIMEPIRIDE
    Glimepiride at No. 1, Lutai Road, H...
    Issue/Submission Date
    2017-11-22
    2021-11-25
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    • FDA
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    Icosapent Ethyl

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34361
    Active
    ETHYL ICOSAPENTATE 98
    2020-03-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10044
    ETHYL ICOSAPENTATE at No. 1, Lutai ...
    2023-04-05
    Written Confirmation

    Close WC

    Application Number
    34361
    305MF10044
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ETHYL ICOSAPENTATE 98
    ETHYL ICOSAPENTATE at No. 1, Lutai ...
    Issue/Submission Date
    2020-03-10
    2023-04-05
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    • FDA
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    Metamizole

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    USDMF

    Found USDMF

    31035
    Active
    DIPYRONE (METAMIZOLE SODIUM MONOHYD...
    2016-10-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-356 - Rev 04
    Valid
    Metamizole sodium monohydrate
    2017-08-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31035
    R1-CEP 2001-356 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DIPYRONE (METAMIZOLE SODIUM MONOHYD...
    Metamizole sodium monohydrate
    Issue/Submission Date
    2016-10-19
    2017-08-11
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    • FDA
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    Phenobarbital

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    USDMF

    Found USDMF

    27827
    Active
    PHENOBARBITAL
    2013-12-01
    CEP/COS

    Found CEP/COS

    CEP 2017-269 - Rev 01
    Valid
    Phenobarbital
    2023-11-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27827
    CEP 2017-269 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PHENOBARBITAL
    Phenobarbital
    Issue/Submission Date
    2013-12-01
    2023-11-03
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    • FDA
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    Trimethoprim

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    USDMF

    Found USDMF

    13144
    Active
    TRIMETHOPRIM USP
    1998-08-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-195 - Rev 04
    Valid
    Trimethoprim
    2015-08-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13144
    R1-CEP 2003-195 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TRIMETHOPRIM USP
    Trimethoprim
    Issue/Submission Date
    1998-08-18
    2015-08-24
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    Hydrocortisone

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    USDMF

    Caution USDMF

    11606
    Inactive
    HYDROCORTISONE
    1995-07-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-176 - Rev 00
    Valid
    Hydrocortisone
    2021-10-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11606
    R0-CEP 2019-176 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    HYDROCORTISONE
    Hydrocortisone
    Issue/Submission Date
    1995-07-27
    2021-10-06
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    • FDA
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    Ibuprofen

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    11243
    Inactive
    IBUPROFEN BP 88/USP XXII
    1994-11-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-023 - Rev 06
    Valid
    Ibuprofen
    2022-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11243
    R1-CEP 2004-023 - Rev 06
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    IBUPROFEN BP 88/USP XXII
    Ibuprofen
    Issue/Submission Date
    1994-11-29
    2022-12-05
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    • FDA
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    Aspirin

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    26844
    Active
    ASPIRIN REFINED
    2013-01-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26844
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ASPIRIN REFINED
    Issue/Submission Date
    2013-01-18
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    Aspirin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29793
    Active
    ASPIRIN/STARCH/POVIDONE DC-90
    2015-10-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29793
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ASPIRIN/STARCH/POVIDONE DC-90
    Issue/Submission Date
    2015-10-12
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    • FDA
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    Calcium Polycarbophil

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    USDMF

    Found USDMF

    37983
    Active
    CALCIUM POLYCARBOPHIL
    2023-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37983
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CALCIUM POLYCARBOPHIL
    Issue/Submission Date
    2023-04-26
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    Hydrocortisone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33073
    Active
    HYDROCORTISONE
    2018-10-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33073
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HYDROCORTISONE
    Issue/Submission Date
    2018-10-04
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    Hydrocortisone Acetate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37653
    Active
    HYDROCORTISONE ACETATE
    2022-12-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37653
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HYDROCORTISONE ACETATE
    Issue/Submission Date
    2022-12-06
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    • FDA
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    Ibuprofen

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15511
    Active
    IBUPROFEN
    2001-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15511
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IBUPROFEN
    Issue/Submission Date
    2001-07-03
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    Ibuprofen Sodium

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    USDMF

    Found USDMF

    28403
    Active
    IBUPROFEN SODIUM
    2014-06-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28403
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IBUPROFEN SODIUM
    Issue/Submission Date
    2014-06-10
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    Icosapent Ethyl

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35160
    Active
    ETHYL ICOSAPENTATE 70
    2020-09-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35160
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ETHYL ICOSAPENTATE 70
    Issue/Submission Date
    2020-09-08
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    • FDA
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    Meloxicam

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    USDMF

    Found USDMF

    24476
    Active
    MELOXICAM
    2010-12-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24476
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    MELOXICAM
    Issue/Submission Date
    2010-12-08
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    • FDA
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    Omega-3-Acid Ethyl Esters 90

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29184
    Active
    OMEGA-3-ACID-ETHYL ESTERS
    2015-02-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29184
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    OMEGA-3-ACID-ETHYL ESTERS
    Issue/Submission Date
    2015-02-02
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    • FDA
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    Phenazon

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2002-093 - Rev 03
    Valid
    Phenazone
    2017-07-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2002-093 - Rev 03
    Status
    Valid
     
    Filing Details
    Phenazone
    Issue/Submission Date
    2017-07-20
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    Piperidin-1-Yl-Acetic Acid

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    221MF10201
    Pipemidic acid hydrate at No. 14, D...
    2009-09-14
    Written Confirmation

    Close WC

    Application Number
    221MF10201
    Status
     
    Filing Details
    Pipemidic acid hydrate at No. 14, D...
    Issue/Submission Date
    2009-09-14
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    • FDA
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    Prednisolone

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-204 - Rev 00
    Valid
    Prednisolone
    2022-04-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2020-204 - Rev 00
    Status
    Valid
     
    Filing Details
    Prednisolone
    Issue/Submission Date
    2022-04-29
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    Prednisone

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    USDMF

    Found USDMF

    35461
    Active
    PREDNISONE
    2020-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35461
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PREDNISONE
    Issue/Submission Date
    2020-12-22
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    Prednisone Acetate

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    USDMF

    Found USDMF

    34479
    Active
    PREDNISONE ACETATE
    2020-02-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34479
    Status
    Active
    Fees Paid
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    PREDNISONE ACETATE
    Issue/Submission Date
    2020-02-18
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    CEP/COS

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    R1-CEP 2003-059 - Rev 05
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    Propyphenazone
    2022-03-14
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    Sevelamer Carbonate

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    35326
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    SEVELAMER CARBONATE
    2020-11-02
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    219MF10215
    Theophylline at No. 14 Dongyi Road,...
    2007-06-25
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    Application Number
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    Theophylline at No. 14 Dongyi Road,...
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    2007-06-25
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    26132
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    AMLODIPINE BESYLATE
    2012-05-25
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    Application Number
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    AMLODIPINE BESYLATE
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    2012-05-25
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    17263
    Inactive
    HYDROCORTISONE ACETATE
    2004-03-15
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    Application Number
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    2004-03-15
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    17302
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    IRISQUINONE
    2004-03-18
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    Application Number
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    2004-03-18
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    USDMF

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    10719
    Inactive
    FACILITY AND PROCEDURES IN ZIBO, SH...
    1994-01-20
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    Application Number
    10719
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    N/A
     
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    FACILITY AND PROCEDURES IN ZIBO, SH...
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    1994-01-20
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