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    01 Adenosine (1)

    02 Alfuzosin HCl (1)

    03 Aripiprazole (1)

    04 Azithromycin (3)

    05 Bethanechol (1)

    06 Captopril (1)

    07 Carbopol 940 API (1)

    08 Cefotaxime (1)

    09 Ceftazidime (1)

    10 Ceftriaxone (1)

    11 Cefuroxime Axetil (3)

    12 Cefuroxime Sodium (1)

    13 Chlorothiazide Sodium (1)

    14 Ciprofloxacin Hydrochloride (1)

    15 Citalopram Hydrobromide (2)

    16 Clarithromycin (2)

    17 Clopidogrel (1)

    18 Dapagliflozin Propanediol Monohydrate (1)

    19 Deferasirox (1)

    20 Desvenlafaxine Succinate (1)

    21 Dextrocarbinol (1)

    22 Dextromethorphan Hydrobromide (2)

    23 Dextropropoxyphene HCl (1)

    24 Diacerein (1)

    25 Divalproex Sodium (1)

    26 Donepezil (1)

    27 Doxazosin Mesylate (1)

    28 Duloxetine (1)

    29 Empagliflozin (1)

    30 Enalapril Maleate (1)

    31 Entacapone (1)

    32 Epinephrine (1)

    33 Eszopiclone (1)

    34 Famotidine (1)

    35 Felodipine (1)

    36 Fesoterodine (1)

    37 Fexofenadine Hydrochloride (2)

    38 Fluconazole (1)

    39 Fluoxetine Hydrochloride (2)

    40 Fosaprepitant (1)

    41 Granisetron Hydrochloride (1)

    42 Insulin Glargine (1)

    43 Lansoprazole (1)

    44 Linagliptin (1)

    45 Metformin (1)

    46 Nadifloxacin (1)

    47 Niacin (1)

    48 Nicardipine Hydrochloride (1)

    49 Nizatidine (1)

    50 Octreotide Acetate (1)

    51 Omeprazole (1)

    52 Oxybutynin Hydrochloride (1)

    53 Paliperidone (1)

    54 Palonosetron (1)

    55 Pantoprazole Sodium (1)

    56 Pidotimod (1)

    57 Pioglitazone Hydrochloride (1)

    58 Piroxicam (1)

    59 Pramipexole Dihydrochloride (1)

    60 Propoxyphene Napsylate (1)

    61 Ranitidine Hydrochloride (2)

    62 Regadenoson Monohydrate (1)

    63 Saxagliptin Hydrochloride (1)

    64 Sitagliptin Phosphate (1)

    65 Tamsulosin (1)

    66 Trandolapril (1)

    67 Valacyclovir Hydrochloride (1)

    68 Vitamin B12 (1)

    69 Ziprasidone Hydrochloride (1)

    70 Zoledronic Acid (1)

    71 Zolpidem Tartrate (1)

    72 Zonisamide (1)

    73 Blank (4)

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    01 Active (38)

    02 Inactive (38)

    03 Blank (10)

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    01 Expired (3)

    02 Valid (5)

    03 Withdrawn by Holder (8)

    04 Blank (70)

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    01 220MF10108 (1)

    02 303MF10152 (1)

    03 Blank (84)

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    01 WC-0075 (5)

    02 WC-0075A (1)

    03 WC-0075a3 (4)

    04 WC-0414 (1)

    05 Blank (75)

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    Dextromethorphan Hydrobromide

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    USDMF

    Found USDMF

    11935
    Active
    DEXTROMETHORPHAN HYDROBROMIDE USP
    1996-04-18
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-053 - Rev 04
    Valid
    Dextromethorphan hydrobromide
    2017-03-21
    Japanese DMF

    Found JDMF

    303MF10152
    Dextromethorphan hydrobromic acid h...
    2021-09-28
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Dextromethorphan Hydrobromide (EP/B...
    2019-07-22
    Application Number
    11935
    R1-CEP 1998-053 - Rev 04
    303MF10152
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-21
    Filing Details
    DEXTROMETHORPHAN HYDROBROMIDE USP
    Dextromethorphan hydrobromide
    Dextromethorphan hydrobromic acid h...
    Dextromethorphan Hydrobromide (EP/B...
    Issue/Submission Date
    1996-04-18
    2017-03-21
    2021-09-28
    2019-07-22
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    Adenosine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20071
    Active
    ADENOSINE USP
    2007-05-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-258 - Rev 02
    Valid
    Adenosine
    2022-05-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Adenosine (EP/USP)
    2019-07-22
    Application Number
    20071
    R1-CEP 2008-258 - Rev 02
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-21
    Filing Details
    ADENOSINE USP
    Adenosine
    Adenosine (EP/USP)
    Issue/Submission Date
    2007-05-15
    2022-05-24
    2019-07-22
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    Tamsulosin

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    USDMF

    Found USDMF

    20095
    Active
    TAMSULOSIN HYDROCHLORIDE
    2006-12-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-234 - Rev 00
    Valid
    Tamsulosin hydrochloride
    2014-03-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Tamsulosin Hydrochloride (EP)
    2019-07-22
    Application Number
    20095
    R1-CEP 2007-234 - Rev 00
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-21
    Filing Details
    TAMSULOSIN HYDROCHLORIDE
    Tamsulosin hydrochloride
    Tamsulosin Hydrochloride (EP)
    Issue/Submission Date
    2006-12-23
    2014-03-07
    2019-07-22
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    Captopril

    PDF Supplier PDF
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    USDMF

    Found USDMF

    8028
    Active
    CAPTOPRIL
    1989-04-24
    CEP/COS

    Found CEP/COS

    R1-CEP 1998-052 - Rev 04
    Valid
    Captopril
    2014-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8028
    R1-CEP 1998-052 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CAPTOPRIL
    Captopril
    Issue/Submission Date
    1989-04-24
    2014-06-24
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    Bethanechol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    16119
    Active
    BETHANECHOL CHLORIDE USP
    2002-08-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075
    Expired
    Bethanecol Chloride (USP)
    2019-07-22
    Application Number
    16119
    Indian CDSCO WC-0075
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    BETHANECHOL CHLORIDE USP
    Bethanecol Chloride (USP)
    Issue/Submission Date
    2002-08-27
    2019-07-22
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    Ceftriaxone

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    USDMF

    Found USDMF

    16650
    Active
    STERILE CEFTRIAXONE SODIUM USP
    2003-06-16
    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-203 - Rev 01
    Withdrawn by Holder
    Ceftriaxone sodium, Sterile
    2011-05-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16650
    R1-CEP 2002-203 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    STERILE CEFTRIAXONE SODIUM USP
    Ceftriaxone sodium, Sterile
    Issue/Submission Date
    2003-06-16
    2011-05-23
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    Cefuroxime Axetil

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    USDMF

    Caution USDMF

    15411
    Inactive
    CEFUROXIME AXETIL(CRYSTALLINE) USP
    2001-05-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-051 - Rev 01
    Valid
    Cefuroxime axetil, Amorphous
    2009-12-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15411
    R1-CEP 2003-051 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFUROXIME AXETIL(CRYSTALLINE) USP
    Cefuroxime axetil, Amorphous
    Issue/Submission Date
    2001-05-01
    2009-12-17
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    Desvenlafaxine Succinate

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    USDMF

    Found USDMF

    25656
    Active
    DESVENLAFAXINE SUCCINATE MONOHYDRAT...
    2012-01-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075a3
    Expired
    Desvenlafaxine Succinate Monohydrat...
    2020-10-16
    Application Number
    25656
    Indian CDSCO WC-0075a3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    DESVENLAFAXINE SUCCINATE MONOHYDRAT...
    Desvenlafaxine Succinate Monohydrat...
    Issue/Submission Date
    2012-01-13
    2020-10-16
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    Donepezil

    PDF Supplier PDF
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    USDMF

    Found USDMF

    21923
    Active
    DONEPEZIL HYDROCHLORIDE
    2008-08-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0075a3
    Expired
    Donepezil HCl IH
    2020-10-16
    Application Number
    21923
    Indian CDSCO WC-0075a3
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-21
    Filing Details
    DONEPEZIL HYDROCHLORIDE
    Donepezil HCl IH
    Issue/Submission Date
    2008-08-29
    2020-10-16
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    Entacapone

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    USDMF

    Found USDMF

    19385
    Active
    ENTACAPONE USP
    2006-03-01
    CEP/COS

    Caution CEP/COS

    R0-CEP 2011-211 - Rev 00
    Withdrawn by Holder
    Entacapone
    2012-10-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19385
    R0-CEP 2011-211 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    ENTACAPONE USP
    Entacapone
    Issue/Submission Date
    2006-03-01
    2012-10-15
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