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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Symed Labs

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    Symed Labs
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    India
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    #8-2-293/174/3, Beside BN Reddy Colony, Road No.14, Banjara Hills, Hyderabad-500034. Telangana
    Telephone
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    +91 40 23635000
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    enquiries@pharmacompass.com
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    https://www.symedlabs.com/#
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    • FDA
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    Brimonidine Tartrate

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    USDMF

    Found USDMF

    22230
    Active
    BRIMONIDINE TARTRATE
    2008-12-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-124 - Rev 00
    Valid
    Brimonidine tartrate
    2020-05-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Brimonidine Tartrate (IH)
    2019-10-07
    Application Number
    22230
    R0-CEP 2018-124 - Rev 00
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-09-08
    Filing Details
    BRIMONIDINE TARTRATE
    Brimonidine tartrate
    Brimonidine Tartrate (IH)
    Issue/Submission Date
    2008-12-01
    2020-05-14
    2019-10-07
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    • FDA
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    Deferasirox

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    USDMF

    Found USDMF

    31877
    Active
    DEFERASIROX
    2019-11-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-038 - Rev 00
    Valid
    Deferasirox
    2023-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0451
    Expired
    Deferasirox IH
    2019-09-12
    Application Number
    31877
    R0-CEP 2021-038 - Rev 00
    Indian CDSCO WC-0451
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-09-11
    Filing Details
    DEFERASIROX
    Deferasirox
    Deferasirox IH
    Issue/Submission Date
    2019-11-20
    2023-07-07
    2019-09-12
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    • FDA
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    Hydroxyzine Dihydrochloride

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    USDMF

    Found USDMF

    19596
    Active
    HYDROXYZINE HYDROCHLORIDE
    2006-07-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-186 - Rev 00
    Valid
    Hydroxyzine hydrochloride
    2021-07-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0451
    Expired
    Hydroxyzine Hydrochloride EP/USP/IP
    2019-09-12
    Application Number
    19596
    R1-CEP 2015-186 - Rev 00
    Indian CDSCO WC-0451
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-09-11
    Filing Details
    HYDROXYZINE HYDROCHLORIDE
    Hydroxyzine hydrochloride
    Hydroxyzine Hydrochloride EP/USP/IP
    Issue/Submission Date
    2006-07-12
    2021-07-12
    2019-09-12
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    • FDA
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    Ketorolac Trometamol

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    USDMF

    Found USDMF

    26870
    Active
    KETOROLAC TROMETHAMINE
    2013-02-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-046 - Rev 00
    Valid
    Ketorolac trometamol
    2021-06-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Ketorolac Tromethamine (USP/Ph. Eur...
    2019-10-07
    Application Number
    26870
    R1-CEP 2015-046 - Rev 00
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-09-08
    Filing Details
    KETOROLAC TROMETHAMINE
    Ketorolac trometamol
    Ketorolac Tromethamine (USP/Ph. Eur...
    Issue/Submission Date
    2013-02-07
    2021-06-04
    2019-10-07
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    • FDA
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    Meclizine Hydrochloride

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    USDMF

    Found USDMF

    25418
    Active
    MECLIZINE HYDROCHLORIDE
    2011-10-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-242 - Rev 00
    Valid
    Meclozine dihydrochloride
    2021-09-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Meclizine Hydrochloride (USP/EP/IP)
    2019-10-07
    Application Number
    25418
    R1-CEP 2015-242 - Rev 00
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-09-08
    Filing Details
    MECLIZINE HYDROCHLORIDE
    Meclozine dihydrochloride
    Meclizine Hydrochloride (USP/EP/IP)
    Issue/Submission Date
    2011-10-25
    2021-09-10
    2019-10-07
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    • FDA
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    Rivaroxaban

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    USDMF

    Found USDMF

    28807
    Active
    RIVAROXABAN
    2014-11-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-091 - Rev 00
    Valid
    Rivaroxaban
    2023-07-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382
    Expired
    Rivaroxaban IH
    2019-12-02
    Application Number
    28807
    R0-CEP 2021-091 - Rev 00
    Indian CDSCO WC-0382
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-08
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Rivaroxaban IH
    Issue/Submission Date
    2014-11-06
    2023-07-21
    2019-12-02
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    • FDA
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    Tizanidine HCl

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    USDMF

    Found USDMF

    33900
    Active
    TIZANIDINE HYDROCHLORIDE USP
    2019-07-09
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-256 - Rev 00
    Valid
    Tizanidine hydrochloride
    2023-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382A4
    Expired
    Tizanidine HCl USP/EP
    2021-06-22
    Application Number
    33900
    R0-CEP 2022-256 - Rev 00
    Indian CDSCO WC-0382A4
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-08-08
    Filing Details
    TIZANIDINE HYDROCHLORIDE USP
    Tizanidine hydrochloride
    Tizanidine HCl USP/EP
    Issue/Submission Date
    2019-07-09
    2023-01-05
    2021-06-22
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    • FDA
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    Amisulpride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-147 - Rev 00
    Valid
    Amisulpride, Process-2
    2020-10-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Amisulpride (IP/Ph. Eur.)
    2019-10-07
    Application Number
    R0-CEP 2019-147 - Rev 00
    Indian CDSCO WC-0072
    Status
    Valid
     
    Expired
    2022-09-08
    Filing Details
    Amisulpride, Process-2
    Amisulpride (IP/Ph. Eur.)
    Issue/Submission Date
    2020-10-15
    2019-10-07
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    Amisulpride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-185 - Rev 01
    Valid
    Amisulpride
    2019-02-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0451A2
    Expired
    Amisulpride EP
    2021-04-23
    Application Number
    R1-CEP 2010-185 - Rev 01
    Indian CDSCO WC-0451A2
    Status
    Valid
     
    Expired
    2022-09-11
    Filing Details
    Amisulpride
    Amisulpride EP
    Issue/Submission Date
    2019-02-21
    2021-04-23
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    • FDA
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    Carvedilol

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-239 - Rev 00
    Valid
    Carvedilol
    2022-04-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Carvedilol Ph. Eur
    2019-10-07
    Application Number
    R0-CEP 2019-239 - Rev 00
    Indian CDSCO WC-0072
    Status
    Valid
     
    Expired
    2022-09-08
    Filing Details
    Carvedilol
    Carvedilol Ph. Eur
    Issue/Submission Date
    2022-04-25
    2019-10-07
    ASK
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    • FDA
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    Dronedarone Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    30229
    Active
    DRONEDARONE HYDROCHLORIDE
    2016-01-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Dronedarone Hydrochloride IH
    2019-10-07
    Application Number
    30229
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-09-08
    Filing Details
    DRONEDARONE HYDROCHLORIDE
    Dronedarone Hydrochloride IH
    Issue/Submission Date
    2016-01-22
    2019-10-07
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    • FDA
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    Eszopiclone

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    28171
    Active
    ESZOPICLONE
    2014-04-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Eszopiclone IH/USP
    2019-10-07
    Application Number
    28171
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-09-08
    Filing Details
    ESZOPICLONE
    Eszopiclone IH/USP
    Issue/Submission Date
    2014-04-01
    2019-10-07
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    • FDA
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    Lanthanum Carbonate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28217
    Active
    LANTHANUM CARBONATE
    2014-04-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Lanthanum Carbonate IH
    2019-10-07
    Application Number
    28217
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-09-08
    Filing Details
    LANTHANUM CARBONATE
    Lanthanum Carbonate IH
    Issue/Submission Date
    2014-04-21
    2019-10-07
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    • FDA
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    Levocetirizine Dihydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    22286
    Active
    LEVOCETIRIZINE DIHYDROCHLORIDE
    2008-12-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Levocetirizine Dihydrochloride (IP/...
    2019-10-07
    Application Number
    22286
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-09-08
    Filing Details
    LEVOCETIRIZINE DIHYDROCHLORIDE
    Levocetirizine Dihydrochloride (IP/...
    Issue/Submission Date
    2008-12-15
    2019-10-07
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    • FDA
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    Linezolid

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    20269
    Active
    LINEZOLID (FORM III)
    2007-02-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Linezolid Form III (IH/IP)
    2019-10-07
    Application Number
    20269
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-09-08
    Filing Details
    LINEZOLID (FORM III)
    Linezolid Form III (IH/IP)
    Issue/Submission Date
    2007-02-15
    2019-10-07
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    • FDA
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    Linezolid

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    28642
    Active
    LINEZOLID (FORM-II)
    2014-09-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382
    Expired
    Linezolid IH/USP
    2019-12-02
    Application Number
    28642
    Indian CDSCO WC-0382
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-08
    Filing Details
    LINEZOLID (FORM-II)
    Linezolid IH/USP
    Issue/Submission Date
    2014-09-16
    2019-12-02
    ASK
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    • FDA
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    Meprobamate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    19678
    Active
    MEPROBAMATE USP
    2006-08-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Meprobamate USP
    2019-10-07
    Application Number
    19678
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-09-08
    Filing Details
    MEPROBAMATE USP
    Meprobamate USP
    Issue/Submission Date
    2006-08-14
    2019-10-07
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    • FDA
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    Ondansetron Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-252 - Rev 00
    Valid
    Ondansetron hydrochloride dihydrate
    2021-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382A4
    Expired
    Ondansetron HCl USP/EP
    2021-06-22
    Application Number
    R0-CEP 2019-252 - Rev 00
    Indian CDSCO WC-0382A4
    Status
    Valid
     
    Expired
    2022-08-08
    Filing Details
    Ondansetron hydrochloride dihydrate
    Ondansetron HCl USP/EP
    Issue/Submission Date
    2021-12-06
    2021-06-22
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    • FDA
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    Phentermine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24856
    Active
    PHENTERMINE HYDROCHLORIDE
    2011-04-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Phentermine Hydrochloride USP/Phent...
    2019-10-07
    Application Number
    24856
    Indian CDSCO WC-0072
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-09-08
    Filing Details
    PHENTERMINE HYDROCHLORIDE
    Phentermine Hydrochloride USP/Phent...
    Issue/Submission Date
    2011-04-12
    2019-10-07
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    • FDA
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    Prucalopride Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34862
    Active
    PRUCALOPRIDE SUCCINATE
    2020-09-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382
    Expired
    Prucalopride Succinate IH
    2019-12-02
    Application Number
    34862
    Indian CDSCO WC-0382
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-08-08
    Filing Details
    PRUCALOPRIDE SUCCINATE
    Prucalopride Succinate IH
    Issue/Submission Date
    2020-09-25
    2019-12-02
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    • FDA
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    Racecadotril

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2015-249 - Rev 00
    Valid
    Racecadotril
    2021-07-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Racecadotril (Ph. Eur.)
    2019-10-07
    Application Number
    R1-CEP 2015-249 - Rev 00
    Indian CDSCO WC-0072
    Status
    Valid
     
    Expired
    2022-09-08
    Filing Details
    Racecadotril
    Racecadotril (Ph. Eur.)
    Issue/Submission Date
    2021-07-09
    2019-10-07
    ASK
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    • FDA
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    Carbinoxamine

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    21335
    Active
    CARBINOXAMINE MALEATE USP
    2008-02-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21335
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CARBINOXAMINE MALEATE USP
    Issue/Submission Date
    2008-02-14
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    Hydroxyzine Pamoate

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    USDMF

    Found USDMF

    38535
    Active
    HYDROXYZINE PAMOATE USP
    2023-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38535
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HYDROXYZINE PAMOATE USP
    Issue/Submission Date
    2023-07-03
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    Iloperidone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24932
    Active
    ILOPERIDONE
    2011-05-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24932
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ILOPERIDONE
    Issue/Submission Date
    2011-05-10
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    Iron Sucrose

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32089
    Active
    SUCROFERRIC OXYHYDROXIDE
    2018-04-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32089
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SUCROFERRIC OXYHYDROXIDE
    Issue/Submission Date
    2018-04-28
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    Iron Sucrose

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    USDMF

    Caution USDMF

    20919
    Inactive
    IRON SUCROSE
    2007-10-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Iron Sucrose (liquid) (IH)
    2019-10-07
    Application Number
    20919
    Indian CDSCO WC-0072
    Status
    Inactive
    Fees Paid
    N/A
     
    Expired
    2022-09-08
    Filing Details
    IRON SUCROSE
    Iron Sucrose (liquid) (IH)
    Issue/Submission Date
    2007-10-05
    2019-10-07
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    Sertraline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    38163
    Active
    SERTRALINE HYDROCHLORIDE (FORM-I) U...
    2023-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38163
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SERTRALINE HYDROCHLORIDE (FORM-I) U...
    Issue/Submission Date
    2023-03-16
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    MODAFINIL USP

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    USDMF

    Found USDMF

    38533
    Active
    MODAFINIL USP
    2023-12-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38533
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MODAFINIL USP
    Issue/Submission Date
    2023-12-11
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    BILASTINE (FORM-II)

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    USDMF

    Found USDMF

    38966
    Active
    BILASTINE (FORM-II)
    2023-10-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38966
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BILASTINE (FORM-II)
    Issue/Submission Date
    2023-10-09
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    Tapentadol hydrochloride, Form-A

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2022-252 - Rev 00
    Valid
    Tapentadol hydrochloride, Form-A
    2024-02-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2022-252 - Rev 00
    Status
    Valid
     
    Filing Details
    Tapentadol hydrochloride, Form-A
    Issue/Submission Date
    2024-02-27
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    Agomelatine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Agomelatine (form I) (IH)
    2019-10-07
    Application Number
    Indian CDSCO WC-0072
    Status
     
    Expired
    2022-09-08
    Filing Details
    Agomelatine (form I) (IH)
    Issue/Submission Date
    2019-10-07
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    Bilastine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382A4
    Expired
    Bilastine IH
    2021-06-22
    Application Number
    Indian CDSCO WC-0382A4
    Status
     
    Expired
    2022-08-08
    Filing Details
    Bilastine IH
    Issue/Submission Date
    2021-06-22
    ASK
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    • FDA
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    Cinitapride Hydrogen Tartrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Cintapride Hydrogen Tartrate (IH)
    2019-10-07
    Application Number
    Indian CDSCO WC-0072
    Status
     
    Expired
    2022-09-08
    Filing Details
    Cintapride Hydrogen Tartrate (IH)
    Issue/Submission Date
    2019-10-07
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    Dapoxetine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Dapoxetine Hydrochloride (IH)
    2019-10-07
    Application Number
    Indian CDSCO WC-0072
    Status
     
    Expired
    2022-09-08
    Filing Details
    Dapoxetine Hydrochloride (IH)
    Issue/Submission Date
    2019-10-07
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    Epalrestat

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Epalrestat IH
    2019-10-07
    Application Number
    Indian CDSCO WC-0072
    Status
     
    Expired
    2022-09-08
    Filing Details
    Epalrestat IH
    Issue/Submission Date
    2019-10-07
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    Gemfibrozil

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    18464
    Inactive
    GEIBROZIL
    2005-06-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18464
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    GEIBROZIL
    Issue/Submission Date
    2005-06-29
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    • FDA
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    Hydroxyzine Dihydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Hydroxyzine Hydrochloride (USP/Ph. ...
    2019-10-07
    Application Number
    Indian CDSCO WC-0072
    Status
     
    Expired
    2022-09-08
    Filing Details
    Hydroxyzine Hydrochloride (USP/Ph. ...
    Issue/Submission Date
    2019-10-07
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    Itopride Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Itopride Hydrochloride (IH)
    2019-10-07
    Application Number
    Indian CDSCO WC-0072
    Status
     
    Expired
    2022-09-08
    Filing Details
    Itopride Hydrochloride (IH)
    Issue/Submission Date
    2019-10-07
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    Levosulpiride

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0451
    Expired
    Levosulpride IH
    2019-09-12
    Application Number
    Indian CDSCO WC-0451
    Status
     
    Expired
    2022-09-11
    Filing Details
    Levosulpride IH
    Issue/Submission Date
    2019-09-12
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    Mosapride Citrate

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382A4
    Expired
    Mosapride Citrate Dihydrate IH/JP/I...
    2021-06-22
    Application Number
    Indian CDSCO WC-0382A4
    Status
     
    Expired
    2022-08-08
    Filing Details
    Mosapride Citrate Dihydrate IH/JP/I...
    Issue/Submission Date
    2021-06-22
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    Mosapride Citrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Mosapride Citrate Dihydrarte (IP/IH...
    2019-10-07
    Application Number
    Indian CDSCO WC-0072
    Status
     
    Expired
    2022-09-08
    Filing Details
    Mosapride Citrate Dihydrarte (IP/IH...
    Issue/Submission Date
    2019-10-07
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    Pregabalin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0451A2
    Expired
    Pregabalin EP/USP
    2021-04-23
    Application Number
    Indian CDSCO WC-0451A2
    Status
     
    Expired
    2022-09-11
    Filing Details
    Pregabalin EP/USP
    Issue/Submission Date
    2021-04-23
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    Sibutramine Hydrochloride

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    USDMF

    Caution USDMF

    22921
    Inactive
    SIBUTRAMINE HYDROCHLORIDE MONOHYDRA...
    2009-07-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22921
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SIBUTRAMINE HYDROCHLORIDE MONOHYDRA...
    Issue/Submission Date
    2009-07-01
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    Tapentadol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382A3
    Expired
    Tapentadol dihydrogen phosphate IH
    2020-12-09
    Application Number
    Indian CDSCO WC-0382A3
    Status
     
    Expired
    2022-08-08
    Filing Details
    Tapentadol dihydrogen phosphate IH
    Issue/Submission Date
    2020-12-09
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    Tapentadol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382A4
    Expired
    Tapentadol HCl IH
    2021-06-22
    Application Number
    Indian CDSCO WC-0382A4
    Status
     
    Expired
    2022-08-08
    Filing Details
    Tapentadol HCl IH
    Issue/Submission Date
    2021-06-22
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    Thalidomide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0072
    Expired
    Thalidomide USP
    2019-10-07
    Application Number
    Indian CDSCO WC-0072
    Status
     
    Expired
    2022-09-08
    Filing Details
    Thalidomide USP
    Issue/Submission Date
    2019-10-07
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    Tofisopam

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0382A4
    Expired
    Tofisopam IH/IP
    2021-06-22
    Application Number
    Indian CDSCO WC-0382A4
    Status
     
    Expired
    2022-08-08
    Filing Details
    Tofisopam IH/IP
    Issue/Submission Date
    2021-06-22
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    Ferric Maltol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Glycopyrronium Bromide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
    ASK
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    • FDA
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    Hydroxychloroquine Sulphate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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