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

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    Lee Pharma
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    India
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    Address
    SY. No. : 257 & 258/1, Door No : 11-6/56-C, Opp : IDPL Factory, Moosapet, Balanagar ( Post ), Hyderabad – 500 037,
    Telephone
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    +91 - 40 - 23770338
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    enquiries@pharmacompass.com
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    Bilastine

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    USDMF

    Found USDMF

    36288
    Active
    BILASTINE
    2021-09-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10159
    Bilastine at SY. No. :257 & 258/1, ...
    2021-10-21
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A4
    Expired
    Bilastine IH
    2020-05-29
    Application Number
    36288
    303MF10159
    Indian CDSCO WC-0186A4
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-28
    Filing Details
    BILASTINE
    Bilastine at SY. No. :257 & 258/1, ...
    Bilastine IH
    Issue/Submission Date
    2021-09-16
    2021-10-21
    2020-05-29
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    34572
    Active
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
    2020-02-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-284 - Rev 00
    Valid
    Esomeprazole magnesium trihydrate
    2023-06-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Esomeprazole Magnesium dihydrate (P...
    2019-09-27
    Application Number
    34572
    R1-CEP 2016-284 - Rev 00
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
    Esomeprazole magnesium trihydrate
    Esomeprazole Magnesium dihydrate (P...
    Issue/Submission Date
    2020-02-18
    2023-06-12
    2019-09-27
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    Lansoprazole

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    USDMF

    Found USDMF

    26799
    Active
    LANSOPRAZOLE USP
    2013-01-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-191 - Rev 01
    Valid
    Lansoprazole
    2023-08-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Lansoprazole (USP)
    2019-09-27
    Application Number
    26799
    R1-CEP 2010-191 - Rev 01
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    LANSOPRAZOLE USP
    Lansoprazole
    Lansoprazole (USP)
    Issue/Submission Date
    2013-01-07
    2023-08-01
    2019-09-27
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    Omeprazole

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    USDMF

    Found USDMF

    37921
    Active
    OMEPRAZOLE
    2023-05-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-006 - Rev 03
    Valid
    Omeprazole, Micronised
    2023-01-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Omeprazole (BP/USP/EP)
    2019-09-27
    Application Number
    37921
    R1-CEP 2007-006 - Rev 03
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2022-07-28
    Filing Details
    OMEPRAZOLE
    Omeprazole, Micronised
    Omeprazole (BP/USP/EP)
    Issue/Submission Date
    2023-05-25
    2023-01-23
    2019-09-27
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    35115
    Active
    ROSUVASTATIN CALCIUM USP
    2020-09-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-204 - Rev 00
    Valid
    Rosuvastatin calcium
    2022-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Rosuvastatin Calcium (Ph.Eur)
    2019-09-27
    Application Number
    35115
    R0-CEP 2022-204 - Rev 00
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    ROSUVASTATIN CALCIUM USP
    Rosuvastatin calcium
    Rosuvastatin Calcium (Ph.Eur)
    Issue/Submission Date
    2020-09-27
    2022-12-14
    2019-09-27
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    35198
    Active
    SITAGLIPTIN PHOSPHATE USP
    2020-09-30
    CEP/COS

    Found CEP/COS

    CEP 2022-042 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2024-03-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A4
    Expired
    Sitagliptin Phosphate Monohydrate E...
    2020-05-29
    Application Number
    35198
    CEP 2022-042 - Rev 00
    Indian CDSCO WC-0186A4
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    SITAGLIPTIN PHOSPHATE USP
    Sitagliptin phosphate monohydrate
    Sitagliptin Phosphate Monohydrate E...
    Issue/Submission Date
    2020-09-30
    2024-03-06
    2020-05-29
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    Varenicline Tartrate

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    USDMF

    Found USDMF

    31576
    Active
    VARENICLINE BASE (INTERMEDIATE OF V...
    2017-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10142
    Varenicline Tartrate at SY, No. :25...
    2021-09-02
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A4
    Expired
    Varenicline Tartrate IH
    2020-05-29
    Application Number
    31576
    303MF10142
    Indian CDSCO WC-0186A4
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-28
    Filing Details
    VARENICLINE BASE (INTERMEDIATE OF V...
    Varenicline Tartrate at SY, No. :25...
    Varenicline Tartrate IH
    Issue/Submission Date
    2017-03-30
    2021-09-02
    2020-05-29
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    Esomeprazole Magnesium

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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-334 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate
    2022-05-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0421
    Expired
    Esomeprazole Magnesium Dihydrate IH...
    2018-05-14
    Application Number
    R0-CEP 2021-334 - Rev 00
    Indian CDSCO WC-0421
    Status
    Valid
     
    Expired
    2021-05-16
    Filing Details
    Esomeprazole magnesium dihydrate
    Esomeprazole Magnesium Dihydrate IH...
    Issue/Submission Date
    2022-05-03
    2018-05-14
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    Esomeprazole Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-001 - Rev 00
    Valid
    Esomeprazole sodium
    2022-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Esomeprazole Sodium (IH)
    2019-09-27
    Application Number
    R0-CEP 2022-001 - Rev 00
    Indian CDSCO WC-0186
    Status
    Valid
     
    Expired
    2022-07-28
    Filing Details
    Esomeprazole sodium
    Esomeprazole Sodium (IH)
    Issue/Submission Date
    2022-11-17
    2019-09-27
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    Lacosamide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-223 - Rev 00
    Valid
    Lacosamide
    2021-10-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A2
    Expired
    Lacosamide EP
    2020-05-06
    Application Number
    R0-CEP 2019-223 - Rev 00
    Indian CDSCO WC-0186A2
    Status
    Valid
     
    Expired
    2022-07-28
    Filing Details
    Lacosamide
    Lacosamide EP
    Issue/Submission Date
    2021-10-21
    2020-05-06
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    Linezolid

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    USDMF

    Found USDMF

    37732
    Active
    LINEZOLID USP
    2022-12-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A4
    Expired
    Linezolid USP
    2020-05-29
    Application Number
    37732
    Indian CDSCO WC-0186A4
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-28
    Filing Details
    LINEZOLID USP
    Linezolid USP
    Issue/Submission Date
    2022-12-05
    2020-05-29
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    • FDA
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    Olanzapine

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2017-020 - Rev 00
    Valid
    Olanzapine, Form-I
    2023-05-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Olanzapine (IH)
    2019-09-27
    Application Number
    R1-CEP 2017-020 - Rev 00
    Indian CDSCO WC-0186
    Status
    Valid
     
    Expired
    2022-07-28
    Filing Details
    Olanzapine, Form-I
    Olanzapine (IH)
    Issue/Submission Date
    2023-05-22
    2019-09-27
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    Pantoprazole Sodium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2010-307 - Rev 01
    Valid
    Pantoprazole sodium sesquihydrate
    2023-05-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Pantoprazole Sodium (USP)/Pantopraz...
    2019-09-27
    Application Number
    R1-CEP 2010-307 - Rev 01
    Indian CDSCO WC-0186
    Status
    Valid
     
    Expired
    2022-07-28
    Filing Details
    Pantoprazole sodium sesquihydrate
    Pantoprazole Sodium (USP)/Pantopraz...
    Issue/Submission Date
    2023-05-30
    2019-09-27
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    • FDA
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    Sertraline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37733
    Active
    SERTRALINE HYDROCHLORIDE FORM-II
    2023-04-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Sertraline HCI (Ph. Eur.)
    2019-09-27
    Application Number
    37733
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-28
    Filing Details
    SERTRALINE HYDROCHLORIDE FORM-II
    Sertraline HCI (Ph. Eur.)
    Issue/Submission Date
    2023-04-06
    2019-09-27
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    • FDA
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    Vildagliptin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37495
    Active
    VILDAGLIPTIN
    2022-10-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A4
    Expired
    Vildagliptin IH
    2020-05-29
    Application Number
    37495
    Indian CDSCO WC-0186A4
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-28
    Filing Details
    VILDAGLIPTIN
    Vildagliptin IH
    Issue/Submission Date
    2022-10-03
    2020-05-29
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    Voriconazole

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-306 - Rev 01
    Valid
    Voriconazole
    2022-06-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Voriconazole EP
    2019-09-27
    Application Number
    R1-CEP 2013-306 - Rev 01
    Indian CDSCO WC-0186
    Status
    Valid
     
    Expired
    2022-07-28
    Filing Details
    Voriconazole
    Voriconazole EP
    Issue/Submission Date
    2022-06-21
    2019-09-27
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37040
    Active
    APIXABAN
    2022-08-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37040
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2022-08-25
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    Bempedoic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36010
    Active
    BEMPEDOIC ACID
    2021-06-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36010
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    BEMPEDOIC ACID
    Issue/Submission Date
    2021-06-28
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    Brivaracetam

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    USDMF

    Found USDMF

    39008
    Active
    BRIVARACETAM
    2023-10-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39008
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    BRIVARACETAM
    Issue/Submission Date
    2023-10-09
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    Cariprazine Hydrochloride

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    USDMF

    Found USDMF

    38749
    Active
    CARIPRAZINE HYDROCHLORIDE
    2023-09-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38749
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    CARIPRAZINE HYDROCHLORIDE
    Issue/Submission Date
    2023-09-14
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    Dabigatran Etexilate Mesylate

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    USDMF

    Found USDMF

    36181
    Active
    DABIGATRAN ETEXILATE MESYLATE
    2021-11-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36181
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DABIGATRAN ETEXILATE MESYLATE
    Issue/Submission Date
    2021-11-17
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    Dapagliflozin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36994
    Active
    DAPAGLIFLOZIN
    2023-06-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36994
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    DAPAGLIFLOZIN
    Issue/Submission Date
    2023-06-12
    ASK
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    Dapagliflozin Propanediol Monohydrate

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    USDMF

    Found USDMF

    35792
    Active
    Dapagliflozin Propanediol Monohydra...
    2021-07-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35792
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    Dapagliflozin Propanediol Monohydra...
    Issue/Submission Date
    2021-07-22
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    Dexlansoprazole

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    USDMF

    Found USDMF

    38183
    Active
    DEXLANSOPRAZOLE SESQUIHYDRATE
    2023-04-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38183
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    DEXLANSOPRAZOLE SESQUIHYDRATE
    Issue/Submission Date
    2023-04-03
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    Empagliflozin

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    USDMF

    Found USDMF

    36162
    Active
    EMPAGLIFLOZIN
    2022-08-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36162
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    EMPAGLIFLOZIN
    Issue/Submission Date
    2022-08-16
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    Flurbiprofen

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    306MF10014
    Flurbiprofen at SY. No. :257 & 258/...
    2024-01-24
    Written Confirmation

    Close WC

    Application Number
    306MF10014
    Status
     
    Filing Details
    Flurbiprofen at SY. No. :257 & 258/...
    Issue/Submission Date
    2024-01-24
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    Itraconazole

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2007-161 - Rev 00
    Expired
    Itraconazole
    2009-09-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Itraconazole (BP)
    2019-09-27
    Application Number
    R0-CEP 2007-161 - Rev 00
    Indian CDSCO WC-0186
    Status
    Expired
     
    Expired
    2022-07-28
    Filing Details
    Itraconazole
    Itraconazole (BP)
    Issue/Submission Date
    2009-09-21
    2019-09-27
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    Linagliptin

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    USDMF

    Found USDMF

    36923
    Active
    LINAGLIPTIN
    2023-09-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36923
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LINAGLIPTIN
    Issue/Submission Date
    2023-09-02
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    Lurasidone Hydrochloride

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    USDMF

    Found USDMF

    36492
    Active
    LURASIDONE HYDROCHLORIDE
    2021-12-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36492
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    LURASIDONE HYDROCHLORIDE
    Issue/Submission Date
    2021-12-10
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    Mirogabalin Besylate

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    USDMF

    Found USDMF

    38908
    Active
    MIROGABALIN BESYLATE
    2023-09-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38908
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    MIROGABALIN BESYLATE
    Issue/Submission Date
    2023-09-20
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    Raltegravir Potassium

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    USDMF

    Found USDMF

    38431
    Active
    RALTEGRAVIR INTERMEDIATE "BENZYL (2...
    2023-05-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38431
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    RALTEGRAVIR INTERMEDIATE "BENZYL (2...
    Issue/Submission Date
    2023-05-25
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    Relugolix

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    USDMF

    Found USDMF

    37365
    Active
    RELUGOLIX
    2022-09-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37365
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    RELUGOLIX
    Issue/Submission Date
    2022-09-06
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    Rivaroxaban

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    USDMF

    Found USDMF

    36672
    Active
    RIVAROXABAN
    2022-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36672
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    RIVAROXABAN
    Issue/Submission Date
    2022-06-06
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    37299
    Active
    SITAGLIPTIN PHOSPHATE USP (ROUTE-1)
    2022-07-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37299
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    SITAGLIPTIN PHOSPHATE USP (ROUTE-1)
    Issue/Submission Date
    2022-07-19
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    Tamsulosin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2022-152 - Rev 00
    Valid
    Tamsulosin hydrochloride
    2023-12-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2022-152 - Rev 00
    Status
    Valid
     
    Filing Details
    Tamsulosin hydrochloride
    Issue/Submission Date
    2023-12-12
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    Tegoprazan

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    USDMF

    Found USDMF

    39156
    Active
    TEGOPRAZAN
    2023-11-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39156
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    TEGOPRAZAN
    Issue/Submission Date
    2023-11-18
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    Tofacitinib Citrate

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    USDMF

    Found USDMF

    37496
    Active
    TOFACITINIB CITRATE
    2022-11-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37496
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    TOFACITINIB CITRATE
    Issue/Submission Date
    2022-11-04
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    Upadacitinib

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    USDMF

    Found USDMF

    39581
    Active
    UPADACITINIB
    2024-03-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39581
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    UPADACITINIB
    Issue/Submission Date
    2024-03-12
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    Varenicline Tartrate

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    USDMF

    Found USDMF

    33016
    Active
    VARENICLINE TARTRATE
    2018-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33016
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    VARENICLINE TARTRATE
    Issue/Submission Date
    2018-11-29
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    Viloxazine Hydrochloride

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    USDMF

    Found USDMF

    39582
    Active
    VILOXAZINE HYDROCHLORIDE
    2024-03-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39582
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    VILOXAZINE HYDROCHLORIDE
    Issue/Submission Date
    2024-03-12
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    Vonoprazan Fumarate

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    USDMF

    Found USDMF

    38701
    Active
    VONOPRAZAN FUMARATE
    2023-09-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38701
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    VONOPRAZAN FUMARATE
    Issue/Submission Date
    2023-09-02
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    OLANZAPINE (FORM-I)

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    USDMF

    Found USDMF

    39150
    Active
    OLANZAPINE (FORM-I)
    2023-12-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39150
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    OLANZAPINE (FORM-I)
    Issue/Submission Date
    2023-12-05
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    TEGOPRAZAN CRYSTALLINE

    PDF Supplier PDF
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    USDMF

    Found USDMF

    39217
    Active
    TEGOPRAZAN CRYSTALLINE
    2023-11-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39217
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    TEGOPRAZAN CRYSTALLINE
    Issue/Submission Date
    2023-11-29
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    ELETROMBOPAG OLAMINE

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    USDMF

    Found USDMF

    39583
    Active
    ELETROMBOPAG OLAMINE
    2024-03-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39583
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    ELETROMBOPAG OLAMINE
    Issue/Submission Date
    2024-03-02
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    Clopidogrel

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Clopidogrel Bisulphate (USP)
    2019-09-27
    Application Number
    Indian CDSCO WC-0186
    Status
     
    Expired
    2022-07-28
    Filing Details
    Clopidogrel Bisulphate (USP)
    Issue/Submission Date
    2019-09-27
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    Pregabalin

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Pregabalin (IH)
    2019-09-27
    Application Number
    Indian CDSCO WC-0186
    Status
     
    Expired
    2022-07-28
    Filing Details
    Pregabalin (IH)
    Issue/Submission Date
    2019-09-27
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    Rabeprazole

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Rabeprazole Sodium (IH)
    2019-09-27
    Application Number
    Indian CDSCO WC-0186
    Status
     
    Expired
    2022-07-28
    Filing Details
    Rabeprazole Sodium (IH)
    Issue/Submission Date
    2019-09-27
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    Venlafaxine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Venlafaxine HCI (Ph. Eur.)
    2019-09-27
    Application Number
    Indian CDSCO WC-0186
    Status
     
    Expired
    2022-07-28
    Filing Details
    Venlafaxine HCI (Ph. Eur.)
    Issue/Submission Date
    2019-09-27
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    Ivabradine Hydrochloride

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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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    Sacubitril Sodium

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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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