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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Solara Active Pharma Sciences

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    Solara Active Pharma Sciences
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    3rd & 4th Floor, Batra Centre, No.28, Sardar Patel Road, Guindy, Chennai – 600 032, Tamilnadu
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    +91 44 4344 6700
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    enquiries@pharmacompass.com
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    https://solara.co.in/
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    • FDA
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    Levetiracetam

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    USDMF

    Found USDMF

    26500
    Active
    LEVETIRACETAM USP
    2012-09-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-324 - Rev 01
    Valid
    Levetiracetam
    2020-10-20
    Japanese DMF

    Found JDMF

    302MF10081
    Levetiracetam at 2nd Floor, Admin B...
    2020-07-09
    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Levetiracetam USP/EP
    2022-09-30
    Application Number
    26500
    R1-CEP 2012-324 - Rev 01
    302MF10081
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-04
    Filing Details
    LEVETIRACETAM USP
    Levetiracetam
    Levetiracetam at 2nd Floor, Admin B...
    Levetiracetam USP/EP
    Issue/Submission Date
    2012-09-27
    2020-10-20
    2020-07-09
    2022-09-30
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    Oseltamivir Phosphate

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    USDMF

    Found USDMF

    22926
    Active
    OSELTAMIVIR PHOSPHATE
    2009-07-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2015-348 - Rev 01
    Valid
    Oseltamivir phosphate
    2021-12-03
    Japanese DMF

    Found JDMF

    305MF10097
    Oseltamivir Phosphate at No 120 A&B...
    2023-08-22
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    Oseltamivir Phosphate IP/BP/EP/USP
    2021-08-06
    Application Number
    22926
    R0-CEP 2015-348 - Rev 01
    305MF10097
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2024-03-04
    Filing Details
    OSELTAMIVIR PHOSPHATE
    Oseltamivir phosphate
    Oseltamivir Phosphate at No 120 A&B...
    Oseltamivir Phosphate IP/BP/EP/USP
    Issue/Submission Date
    2009-07-08
    2021-12-03
    2023-08-22
    2021-08-06
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    • FDA
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    Aprepitant

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    USDMF

    Found USDMF

    29215
    Active
    APREPITANT
    2015-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    305MF10125
    Aprepitant at 2nd Floor, Admin Bloc...
    2023-11-29
    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Aprepitant USP
    2022-09-30
    Application Number
    29215
    305MF10125
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-04
    Filing Details
    APREPITANT
    Aprepitant at 2nd Floor, Admin Bloc...
    Aprepitant USP
    Issue/Submission Date
    2015-03-27
    2023-11-29
    2022-09-30
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    • FDA
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    Celecoxib

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    USDMF

    Found USDMF

    28020
    Active
    CELECOXIB USP
    2014-02-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-222 - Rev 00
    Valid
    Celecoxib
    2021-06-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Celecoxib USP/EP
    2022-09-30
    Application Number
    28020
    R1-CEP 2014-222 - Rev 00
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-04
    Filing Details
    CELECOXIB USP
    Celecoxib
    Celecoxib USP/EP
    Issue/Submission Date
    2014-02-19
    2021-06-01
    2022-09-30
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    • FDA
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    Dextromethorphan Hydrobromide

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    USDMF

    Found USDMF

    26762
    Active
    DEXTROMETHORPHAN HYDROBROMIDE MONOH...
    2012-12-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-288 - Rev 00
    Valid
    Dextromethorphan hydrobromide
    2022-06-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Dextromethorphan Hydrobromide USP/E...
    2022-09-30
    Application Number
    26762
    R1-CEP 2013-288 - Rev 00
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-04
    Filing Details
    DEXTROMETHORPHAN HYDROBROMIDE MONOH...
    Dextromethorphan hydrobromide
    Dextromethorphan Hydrobromide USP/E...
    Issue/Submission Date
    2012-12-26
    2022-06-28
    2022-09-30
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    Gabapentin

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    USDMF

    Found USDMF

    17543
    Active
    GABAPENTIN USP
    2004-07-19
    CEP/COS

    Found CEP/COS

    CEP 2011-154 - Rev 03
    Valid
    Gabapentin
    2023-09-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Gabapentine USP/EP
    2022-09-30
    Application Number
    17543
    CEP 2011-154 - Rev 03
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-04
    Filing Details
    GABAPENTIN USP
    Gabapentin
    Gabapentine USP/EP
    Issue/Submission Date
    2004-07-19
    2023-09-07
    2022-09-30
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    • FDA
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    Ibuprofen

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    USDMF

    Found USDMF

    7053
    Active
    IBUPROFEN USP
    1987-07-03
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-061 - Rev 15
    Valid
    Ibuprofen, “S250”; “S380”; ...
    2022-10-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Ibuprofen BP/EP/USP/Ibuprofen ArGin...
    2022-09-30
    Application Number
    7053
    R1-CEP 1996-061 - Rev 15
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-04
    Filing Details
    IBUPROFEN USP
    Ibuprofen, “S250”; “S380”; ...
    Ibuprofen BP/EP/USP/Ibuprofen ArGin...
    Issue/Submission Date
    1987-07-03
    2022-10-28
    2022-09-30
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    Lanthanum Carbonate

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    USDMF

    Found USDMF

    37017
    Active
    LANTHANUM CARBONATE TETRAHYDRATE
    2022-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10053
    Lanthanum carbonate octahydrate at ...
    2017-02-28
    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Lanthanum Carbonate IH
    2022-09-30
    Application Number
    37017
    229MF10053
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-04
    Filing Details
    LANTHANUM CARBONATE TETRAHYDRATE
    Lanthanum carbonate octahydrate at ...
    Lanthanum Carbonate IH
    Issue/Submission Date
    2022-03-30
    2017-02-28
    2022-09-30
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    Nizatidine

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    USDMF

    Found USDMF

    13192
    Active
    NIZATIDINE USP
    1998-09-21
    CEP/COS

    Found CEP/COS

    CEP 2000-083 - Rev 10
    Valid
    Nizatidine
    2023-12-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Nizatidine USP/BP/EP
    2022-09-30
    Application Number
    13192
    CEP 2000-083 - Rev 10
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-04
    Filing Details
    NIZATIDINE USP
    Nizatidine
    Nizatidine USP/BP/EP
    Issue/Submission Date
    1998-09-21
    2023-12-19
    2022-09-30
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    Olanzapine

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    USDMF

    Found USDMF

    18260
    Active
    OLANZAPINE USP
    2005-04-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-050 - Rev 02
    Valid
    Olanzapine
    2023-02-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Olanzapine IH
    2022-09-30
    Application Number
    18260
    R1-CEP 2012-050 - Rev 02
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-08-04
    Filing Details
    OLANZAPINE USP
    Olanzapine
    Olanzapine IH
    Issue/Submission Date
    2005-04-08
    2023-02-21
    2022-09-30
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    • FDA
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    Venlafaxine Hydrochloride

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    USDMF

    Found USDMF

    21824
    Active
    VENLAFAXINE HYDROCHLORIDE
    2008-07-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-033 - Rev 00
    Valid
    Venlafaxine hydrochloride, Route SP
    2021-03-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Venlafaxine Hydrochloride IH
    2022-09-30
    Application Number
    21824
    R1-CEP 2014-033 - Rev 00
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-04
    Filing Details
    VENLAFAXINE HYDROCHLORIDE
    Venlafaxine hydrochloride, Route SP
    Venlafaxine Hydrochloride IH
    Issue/Submission Date
    2008-07-28
    2021-03-19
    2022-09-30
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    • FDA
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    Colchicine

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    USDMF

    Found USDMF

    29940
    Active
    COLCHICINE
    2015-10-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-160 - Rev 00
    Valid
    Colchicine
    2022-06-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    ColchicineIP/EP/USP
    2021-08-06
    Application Number
    29940
    R0-CEP 2021-160 - Rev 00
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2024-03-04
    Filing Details
    COLCHICINE
    Colchicine
    ColchicineIP/EP/USP
    Issue/Submission Date
    2015-10-21
    2022-06-13
    2021-08-06
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    Etomidate

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    USDMF

    Found USDMF

    27580
    Active
    ETOMIDATE
    2013-09-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2017-278 - Rev 01
    Valid
    Etomidate
    2022-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    EtomidateEP/BP/USP
    2021-08-06
    Application Number
    27580
    R0-CEP 2017-278 - Rev 01
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2024-03-04
    Filing Details
    ETOMIDATE
    Etomidate
    EtomidateEP/BP/USP
    Issue/Submission Date
    2013-09-20
    2022-06-22
    2021-08-06
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    Flecainide

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    USDMF

    Found USDMF

    33666
    Active
    FLECAINIDE ACETATE USP
    2019-03-29
    CEP/COS

    Found CEP/COS

    CEP 2020-054 - Rev 01
    Valid
    Flecainide acetate
    2023-10-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    Flecainide Acetate USP/EP
    2021-08-06
    Application Number
    33666
    CEP 2020-054 - Rev 01
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2024-03-04
    Filing Details
    FLECAINIDE ACETATE USP
    Flecainide acetate
    Flecainide Acetate USP/EP
    Issue/Submission Date
    2019-03-29
    2023-10-16
    2021-08-06
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    Hydralazine Hydrochloride

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    USDMF

    Found USDMF

    22633
    Active
    HYDRALAZINE HYDROCHLORIDE USP
    2009-03-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-191 - Rev 02
    Valid
    Hydralazine hydrochloride
    2022-06-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    HYDRALAZINE HCL IP/BP/EP/USP
    2021-08-06
    Application Number
    22633
    R1-CEP 2013-191 - Rev 02
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2024-03-04
    Filing Details
    HYDRALAZINE HYDROCHLORIDE USP
    Hydralazine hydrochloride
    HYDRALAZINE HCL IP/BP/EP/USP
    Issue/Submission Date
    2009-03-16
    2022-06-02
    2021-08-06
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    Mesna

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29522
    Active
    MESNA
    2015-06-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-299 - Rev 00
    Valid
    Mesna
    2022-02-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    Mesna EP/BP/USP
    2021-08-06
    Application Number
    29522
    R1-CEP 2015-299 - Rev 00
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2024-03-04
    Filing Details
    MESNA
    Mesna
    Mesna EP/BP/USP
    Issue/Submission Date
    2015-06-29
    2022-02-03
    2021-08-06
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    Mycophenolate Mofetil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33021
    Active
    MYCOPHENOLATE MOFETIL USP
    2018-07-31
    CEP/COS

    Found CEP/COS

    CEP 2019-344 - Rev 01
    Valid
    Mycophenolate mofetil
    2024-01-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0290A3
    Expired
    Mycophenolate Mofetil BP/EP/USP
    2022-04-08
    Application Number
    33021
    CEP 2019-344 - Rev 01
    Indian CDSCO WC-0290A3
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2024-01-11
    Filing Details
    MYCOPHENOLATE MOFETIL USP
    Mycophenolate mofetil
    Mycophenolate Mofetil BP/EP/USP
    Issue/Submission Date
    2018-07-31
    2024-01-23
    2022-04-08
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    Ranitidine Hydrochloride

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    USDMF

    Caution USDMF

    14468
    Inactive
    RANITIDINE HYDROCHLORIDE
    1999-10-06
    CEP/COS

    Found CEP/COS

    CEP 2001-228 - Rev 11
    Valid
    Ranitidine hydrochloride, Form II a...
    2024-03-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Ranitidine Hydrochloride BP/USP
    2022-09-30
    Application Number
    14468
    CEP 2001-228 - Rev 11
    Indian CDSCO WC-0127
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-08-04
    Filing Details
    RANITIDINE HYDROCHLORIDE
    Ranitidine hydrochloride, Form II a...
    Ranitidine Hydrochloride BP/USP
    Issue/Submission Date
    1999-10-06
    2024-03-25
    2022-09-30
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    Succinylcholine Chloride

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    USDMF

    Found USDMF

    22892
    Active
    SUCCINYLCHOLINE CHLORIDE
    2009-06-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-210 - Rev 00
    Valid
    Suxamethonium Chloride
    2021-02-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    Suxamethionium chloride EP/BP/Succi...
    2021-08-06
    Application Number
    22892
    R1-CEP 2013-210 - Rev 00
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2024-03-04
    Filing Details
    SUCCINYLCHOLINE CHLORIDE
    Suxamethonium Chloride
    Suxamethionium chloride EP/BP/Succi...
    Issue/Submission Date
    2009-06-24
    2021-02-15
    2021-08-06
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    Sulfiram

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33722
    Active
    DISULFIRAM USP
    2019-03-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-197 - Rev 00
    Valid
    Disulfiram
    2021-07-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    Disulfiram IP/EP/USP
    2021-08-06
    Application Number
    33722
    R0-CEP 2019-197 - Rev 00
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2024-03-04
    Filing Details
    DISULFIRAM USP
    Disulfiram
    Disulfiram IP/EP/USP
    Issue/Submission Date
    2019-03-31
    2021-07-05
    2021-08-06
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    Bumetanide

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    33261
    Active
    BUMETANIDE USP
    2018-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Bumetanide USP
    2022-09-30
    Application Number
    33261
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    BUMETANIDE USP
    Bumetanide USP
    Issue/Submission Date
    2018-10-27
    2022-09-30
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    Buspirone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    35488
    Active
    BUSPIRONE HYDROCHLORIDE USP
    2020-12-31
    CEP/COS

    Found CEP/COS

    CEP 2021-174 - Rev 00
    Valid
    Buspirone hydrochloride
    2023-12-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35488
    CEP 2021-174 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUSPIRONE HYDROCHLORIDE USP
    Buspirone hydrochloride
    Issue/Submission Date
    2020-12-31
    2023-12-05
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    Carisoprodol

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    USDMF

    Found USDMF

    23100
    Active
    CARISOPRODOL USP
    2009-09-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Carisoprodol USP
    2022-09-30
    Application Number
    23100
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    CARISOPRODOL USP
    Carisoprodol USP
    Issue/Submission Date
    2009-09-09
    2022-09-30
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    Cetirizine Dihydrochloride

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    USDMF

    Found USDMF

    20539
    Active
    CETIRIZINE HYDROCHLORIDE DIHYDROCHL...
    2007-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-144 - Rev 06
    Valid
    Cetirizine dihydrochloride
    2018-08-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20539
    R1-CEP 2001-144 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CETIRIZINE HYDROCHLORIDE DIHYDROCHL...
    Cetirizine dihydrochloride
    Issue/Submission Date
    2007-05-17
    2018-08-08
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    Cinacalcet Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    28156
    Active
    CINACALCET HYDROCHLORIDE
    2014-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0126
    Valid
    Cinacalcet Hydrochloride
    2022-07-15
    Application Number
    28156
    Indian CDSCO WC-0126
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-25
    Filing Details
    CINACALCET HYDROCHLORIDE
    Cinacalcet Hydrochloride
    Issue/Submission Date
    2014-03-27
    2022-07-15
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    Colesevelam Hydrochloride

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    USDMF

    Found USDMF

    23378
    Active
    COLESEVELAM HYDROCHLORIDE
    2009-12-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Colesevelam Hydrochloride IH
    2022-09-30
    Application Number
    23378
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    COLESEVELAM HYDROCHLORIDE
    Colesevelam Hydrochloride IH
    Issue/Submission Date
    2009-12-16
    2022-09-30
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    Cycloserine

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    USDMF

    Found USDMF

    21720
    Active
    CYCLOSERINE USP
    2008-06-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Cycloserine USP/EP
    2022-09-30
    Application Number
    21720
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-04
    Filing Details
    CYCLOSERINE USP
    Cycloserine USP/EP
    Issue/Submission Date
    2008-06-20
    2022-09-30
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    Dipyridamole

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    See Less

    USDMF

    Found USDMF

    35045
    Active
    DIPYRIDAMOLE USP
    2020-08-31
    CEP/COS

    Found CEP/COS

    CEP 2021-019 - Rev 00
    Valid
    Dipyridamole
    2024-02-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35045
    CEP 2021-019 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DIPYRIDAMOLE USP
    Dipyridamole
    Issue/Submission Date
    2020-08-31
    2024-02-27
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    Ethacrynic Acid

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    32069
    Active
    ETHACRYNIC ACID USP
    2017-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0126
    Valid
    Ethacrynic Acid USP
    2022-07-15
    Application Number
    32069
    Indian CDSCO WC-0126
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-25
    Filing Details
    ETHACRYNIC ACID USP
    Ethacrynic Acid USP
    Issue/Submission Date
    2017-09-28
    2022-07-15
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    Ibuprofen

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    12036
    Active
    S-IBUPROFEN
    1996-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0126
    Valid
    Ibuprofen (BP/USP/JP/Ph.Eur)/ S (+)...
    2022-07-15
    Application Number
    12036
    Indian CDSCO WC-0126
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-25
    Filing Details
    S-IBUPROFEN
    Ibuprofen (BP/USP/JP/Ph.Eur)/ S (+)...
    Issue/Submission Date
    1996-07-03
    2022-07-15
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    Ibuprofen Lysinate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    36991
    Active
    IBUPROFEN LYSINE
    2022-03-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Ibuprofen Lysine IH
    2022-09-30
    Application Number
    36991
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-04
    Filing Details
    IBUPROFEN LYSINE
    Ibuprofen Lysine IH
    Issue/Submission Date
    2022-03-29
    2022-09-30
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    Ibuprofen Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    23925
    Active
    IBUPROFEN SODIUM DIHYDRATE
    2010-06-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Ibuprofen Sodium Dihydrate IH
    2022-09-30
    Application Number
    23925
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-04
    Filing Details
    IBUPROFEN SODIUM DIHYDRATE
    Ibuprofen Sodium Dihydrate IH
    Issue/Submission Date
    2010-06-08
    2022-09-30
    ASK
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    Isradipine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    16369
    Active
    ISRADIPINE, USP
    2003-01-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Isradipine BP/USP
    2022-09-30
    Application Number
    16369
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-04
    Filing Details
    ISRADIPINE, USP
    Isradipine BP/USP
    Issue/Submission Date
    2003-01-21
    2022-09-30
    ASK
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    Ketoprofen

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24179
    Active
    KETOPROFEN USP
    2010-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Ketoprofen BP/EP/USP
    2022-09-30
    Application Number
    24179
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    KETOPROFEN USP
    Ketoprofen BP/EP/USP
    Issue/Submission Date
    2010-09-14
    2022-09-30
    ASK
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    • FDA
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    Lurasidone Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    30464
    Active
    LURASIDONE HYDROCHLORIDE
    2016-04-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0126
    Valid
    Lurasidone Hydrochloride
    2022-07-15
    Application Number
    30464
    Indian CDSCO WC-0126
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-25
    Filing Details
    LURASIDONE HYDROCHLORIDE
    Lurasidone Hydrochloride
    Issue/Submission Date
    2016-04-05
    2022-07-15
    ASK
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    Mefenamic Acid

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    19195
    Active
    MEFENAMIC ACID, USP
    2006-02-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-232 - Rev 00
    Valid
    Mefenamic acid, Product code: 05P
    2022-01-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19195
    R1-CEP 2015-232 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MEFENAMIC ACID, USP
    Mefenamic acid, Product code: 05P
    Issue/Submission Date
    2006-02-23
    2022-01-28
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    Mefenamic Acid

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29674
    Active
    MEFENAMIC ACID USP ( PRODUCT CODE :...
    2015-10-12
    CEP/COS

    Found CEP/COS

    CEP 2007-011 - Rev 07
    Valid
    Mefenamic acid
    2023-09-28
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29674
    CEP 2007-011 - Rev 07
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MEFENAMIC ACID USP ( PRODUCT CODE :...
    Mefenamic acid
    Issue/Submission Date
    2015-10-12
    2023-09-28
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    Meprobamate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    19680
    Active
    MEPROBAMATE USP
    2006-08-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Meprobamate USP
    2022-09-30
    Application Number
    19680
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-04
    Filing Details
    MEPROBAMATE USP
    Meprobamate USP
    Issue/Submission Date
    2006-08-07
    2022-09-30
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    • FDA
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    Mesalazine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    35717
    Active
    MESALAMINE USP
    2021-03-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-338 - Rev 00
    Valid
    Mesalazine
    2023-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35717
    R0-CEP 2021-338 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MESALAMINE USP
    Mesalazine
    Issue/Submission Date
    2021-03-30
    2023-01-31
    ASK
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    • FDA
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    Methohexital

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    15353
    Active
    METHOHEXITAL USP
    2001-03-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Methohexital USP
    2022-09-30
    Application Number
    15353
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    METHOHEXITAL USP
    Methohexital USP
    Issue/Submission Date
    2001-03-28
    2022-09-30
    ASK
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    Mycophenolate Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    35722
    Active
    MYCOPHENOLATE SODIUM USP
    2021-03-31
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-335 - Rev 00
    Valid
    Mycophenolate sodium
    2022-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35722
    R0-CEP 2021-335 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MYCOPHENOLATE SODIUM USP
    Mycophenolate sodium
    Issue/Submission Date
    2021-03-31
    2022-10-19
    ASK
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    Pitavastatin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25956
    Active
    PITAVASTATIN CALCIUM
    2012-04-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Pitavastatin Calcium IH
    2022-09-30
    Application Number
    25956
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    PITAVASTATIN CALCIUM
    Pitavastatin Calcium IH
    Issue/Submission Date
    2012-04-11
    2022-09-30
    ASK
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    Posaconazole

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    31577
    Active
    POSACONAZOLE FORM-1
    2017-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0126
    Valid
    Posaconazole IH
    2022-07-15
    Application Number
    31577
    Indian CDSCO WC-0126
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-25
    Filing Details
    POSACONAZOLE FORM-1
    Posaconazole IH
    Issue/Submission Date
    2017-03-30
    2022-07-15
    ASK
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    • FDA
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    Pregabalin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28123
    Active
    PREGABALIN USP
    2014-03-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Pregabalin IH
    2022-09-30
    Application Number
    28123
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    PREGABALIN USP
    Pregabalin IH
    Issue/Submission Date
    2014-03-18
    2022-09-30
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    • FDA
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    Sevelamer Carbonate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    22940
    Active
    SEVELAMER CARBONATE
    2009-07-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Sevelamer Carbonate IH
    2022-09-30
    Application Number
    22940
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    SEVELAMER CARBONATE
    Sevelamer Carbonate IH
    Issue/Submission Date
    2009-07-13
    2022-09-30
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    • FDA
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    Sevelamer Hydrochloride

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    USDMF

    Found USDMF

    21104
    Active
    SEVELAMER HYDROCHLORIDE
    2007-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Sevelamer HCl IH
    2022-09-30
    Application Number
    21104
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    SEVELAMER HYDROCHLORIDE
    Sevelamer HCl IH
    Issue/Submission Date
    2007-11-29
    2022-09-30
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    • FDA
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    Tenofovir Disoproxil Fumarate

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    USDMF

    Found USDMF

    26083
    Active
    TENOFOVIR DISOPROXIL FUMARATE
    2012-05-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    TENOFOVIRDISOPROXIL FUMARATE IH
    2022-09-30
    Application Number
    26083
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-08-04
    Filing Details
    TENOFOVIR DISOPROXIL FUMARATE
    TENOFOVIRDISOPROXIL FUMARATE IH
    Issue/Submission Date
    2012-05-24
    2022-09-30
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    Zileuton

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    USDMF

    Found USDMF

    31578
    Active
    ZILEUTON USP
    2017-07-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0127
    Valid
    Zileuton USP
    2022-09-30
    Application Number
    31578
    Indian CDSCO WC-0127
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-08-04
    Filing Details
    ZILEUTON USP
    Zileuton USP
    Issue/Submission Date
    2017-07-29
    2022-09-30
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    Ibuprofen

    PDF Supplier PDF
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    USDMF

    Found USDMF

    18312
    Active
    IBUPROFEN SODIUM DIHYDRATE
    2005-04-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0127A7
    Expired
    Ibuprofen Arginine
    2021-05-31
    Application Number
    18312
    Indian CDSCO WC-0127A7
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-04
    Filing Details
    IBUPROFEN SODIUM DIHYDRATE
    Ibuprofen Arginine
    Issue/Submission Date
    2005-04-27
    2021-05-31
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    • FDA
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    Methoxsalen

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    USDMF

    Found USDMF

    21862
    Active
    METHOXSALEN USP
    2008-08-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0294
    Expired
    Methoxsalen, USP
    2021-08-06
    Application Number
    21862
    Indian CDSCO WC-0294
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2024-03-04
    Filing Details
    METHOXSALEN USP
    Methoxsalen, USP
    Issue/Submission Date
    2008-08-06
    2021-08-06
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