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    01 1BRECKENRIDGE PHARMS

    02 1AJANTA PHARMA LTD

    03 1AUROBINDO PHARMA LTD

    04 1HIKMA

    05 1MICRO LABS

    06 2MSN PHARMS INC

    07 2PF PRISM CV

    08 3PFIZER

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    10 2YAOPHARMA CO LTD

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    01

    BRECKENRIDGE PHARMS

    U.S.A
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    Medlab Asia & Asia Health
    Not Confirmed
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    RLD :

    TE Code :

    TOFACITINIB

    Brand Name : TOFACITINIB

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Approval Date :

    Application Number : 209633

    RX/OTC/DISCN :

    RLD :

    TE Code :

    Breckenridge Pharmaceutical

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    02

    AJANTA PHARMA LTD

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    AJANTA PHARMA LTD

    India
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    RLD : No

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : TOFACITINIB CITRATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 10MG BASE

    Approval Date : 2021-06-01

    Application Number : 212943

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    MICRO LABS

    India
    Medlab Asia & Asia Health
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    MICRO LABS

    India
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    Medlab Asia & Asia Health
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    RLD : No

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : TOFACITINIB CITRATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 5MG BASE

    Approval Date : 2023-03-13

    Application Number : 209738

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    blank

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    04

    PF PRISM CV

    U.S.A
    Medlab Asia & Asia Health
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    PF PRISM CV

    U.S.A
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    RLD : Yes

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : XELJANZ

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 5MG BASE

    Approval Date : 2012-11-06

    Application Number : 203214

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    05

    PF PRISM CV

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
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    PF PRISM CV

    U.S.A
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    Medlab Asia & Asia Health
    Not Confirmed
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    RLD : Yes

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : XELJANZ

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 10MG BASE

    Approval Date : 2018-05-30

    Application Number : 203214

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    06

    PFIZER

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
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    PFIZER

    U.S.A
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    Medlab Asia & Asia Health
    Not Confirmed
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    RLD : Yes

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : XELJANZ XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 11MG BASE

    Approval Date : 2016-02-23

    Application Number : 208246

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    07

    PFIZER

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
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    PFIZER

    U.S.A
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    Medlab Asia & Asia Health
    Not Confirmed
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    RLD : Yes

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : XELJANZ XR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : EQ 22MG BASE

    Approval Date : 2019-12-12

    Application Number : 208246

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    08

    PFIZER

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
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    PFIZER

    U.S.A
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    Medlab Asia & Asia Health
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    RLD : Yes

    TE Code : AA

    TOFACITINIB CITRATE

    Brand Name : XELJANZ

    Dosage Form : SOLUTION;ORAL

    Dosage Strength : EQ 1MG BASE/ML

    Approval Date : 2020-09-25

    Application Number : 213082

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AA

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    09

    PRINSTON PHARMA INC

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
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    PRINSTON PHARMA INC

    U.S.A
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    Medlab Asia & Asia Health
    Not Confirmed
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    RLD :

    TE Code :

    TOFACITINIB

    Brand Name : TOFACITINIB

    Dosage Form : TABLET;ORAL

    Dosage Strength : 5MG

    Approval Date :

    Application Number : 209923

    RX/OTC/DISCN :

    RLD :

    TE Code :

    blank

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    10

    ZYDUS PHARMS

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
    arrow

    ZYDUS PHARMS

    U.S.A
    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
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    RLD : No

    TE Code :

    TOFACITINIB CITRATE

    Brand Name : TOFACITINIB CITRATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 5MG BASE

    Approval Date : 2023-03-13

    Application Number : 209829

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    blank

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