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    Approved Drug Products containing Methylphenidate listed in the FDA Orange Book. Original Data : FDA Website

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    Methylphenidate

    ACTIVE PHARMA INGREDIENTS

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    01 3ACTAVIS ELIZABETH

    02 4MYLAN TECH VIATRIS

    03 3NEOS THERAPS INC

    04 4NOVEN PHARMS INC

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    01

    NEOS THERAPS INC

    U.S.A
    Pharmaconex 2024
    Not Confirmed
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    NEOS THERAPS INC

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    RLD : Yes

    TE Code :

    METHYLPHENIDATE

    Brand Name : COTEMPLA XR-ODT

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 8.6MG

    Approval Date : 2017-06-19

    Application Number : 205489

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    02

    NEOS THERAPS INC

    U.S.A
    Pharmaconex 2024
    Not Confirmed
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    NEOS THERAPS INC

    U.S.A
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    Pharmaconex 2024
    Not Confirmed
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    RLD : Yes

    TE Code :

    METHYLPHENIDATE

    Brand Name : COTEMPLA XR-ODT

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 17.3MG

    Approval Date : 2017-06-19

    Application Number : 205489

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    NEOS THERAPS INC

    U.S.A
    Pharmaconex 2024
    Not Confirmed
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    NEOS THERAPS INC

    U.S.A
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    Pharmaconex 2024
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    RLD : Yes

    TE Code :

    METHYLPHENIDATE

    Brand Name : COTEMPLA XR-ODT

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 25.9MG

    Approval Date : 2017-06-19

    Application Number : 205489

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    NOVEN PHARMS INC

    U.S.A
    Pharmaconex 2024
    Not Confirmed
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    NOVEN PHARMS INC

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    RLD : Yes

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : DAYTRANA

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 10MG/9HR (1.1MG/HR)

    Approval Date : 2006-04-06

    Application Number : 21514

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    05

    NOVEN PHARMS INC

    U.S.A
    Pharmaconex 2024
    Not Confirmed
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    NOVEN PHARMS INC

    U.S.A
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    Pharmaconex 2024
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    RLD : Yes

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : DAYTRANA

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 15MG/9HR (1.6MG/HR)

    Approval Date : 2006-04-06

    Application Number : 21514

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    06

    NOVEN PHARMS INC

    U.S.A
    Pharmaconex 2024
    Not Confirmed
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    NOVEN PHARMS INC

    U.S.A
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    Pharmaconex 2024
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    RLD : Yes

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : DAYTRANA

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 20MG/9HR (2.2MG/HR)

    Approval Date : 2006-04-06

    Application Number : 21514

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    07

    NOVEN PHARMS INC

    U.S.A
    Pharmaconex 2024
    Not Confirmed
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    NOVEN PHARMS INC

    U.S.A
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    Pharmaconex 2024
    Not Confirmed
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    • WHO-GMP
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    RLD : Yes

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : DAYTRANA

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 30MG/9HR (3.3MG/HR)

    Approval Date : 2006-04-06

    Application Number : 21514

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    08

    MYLAN TECH VIATRIS

    U.S.A
    Pharmaconex 2024
    Not Confirmed
    arrow

    MYLAN TECH VIATRIS

    U.S.A
    arrow
    Pharmaconex 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 10MG/9HR (1.1MG/HR)

    Approval Date : 2022-03-14

    Application Number : 206497

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    MYLAN TECH VIATRIS

    U.S.A
    Pharmaconex 2024
    Not Confirmed
    arrow

    MYLAN TECH VIATRIS

    U.S.A
    arrow
    Pharmaconex 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 15MG/9HR (1.6MG/HR)

    Approval Date : 2022-03-14

    Application Number : 206497

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    MYLAN TECH VIATRIS

    U.S.A
    Pharmaconex 2024
    Not Confirmed
    arrow

    MYLAN TECH VIATRIS

    U.S.A
    arrow
    Pharmaconex 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    RLD : No

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 20MG/9HR (2.2MG/HR)

    Approval Date : 2022-03-14

    Application Number : 206497

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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