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    Approved Drug Products containing Prestwick2_001021 listed in the FDA Orange Book. Original Data : FDA Website

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    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    xyz-pharma-m-2024-09-09

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    Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    xyz-pharma-m-2024-09-09

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    Prestwick2_001021

    ACTIVE PHARMA INGREDIENTS

    FINISHED DOSAGE FORMULATIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    REF. STANDARDS & IMPURITIES

    ANALYTICAL

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    01 2ELITE LABS INC

    02 2GLAXOSMITHKLINE LLC

    03 2NORVIUM BIOSCIENCE

    04 2SMITHKLINE BEECHAM

    05 2WATSON LABS TEVA

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    01

    WATSON LABS TEVA

    Ireland
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    WATSON LABS TEVA

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    RLD : No

    TE Code : AB

    ISRADIPINE

    Brand Name : ISRADIPINE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2.5MG

    Approval Date : 2006-01-05

    Application Number : 77317

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    02

    WATSON LABS TEVA

    Ireland
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    RLD : No

    TE Code : AB

    ISRADIPINE

    Brand Name : ISRADIPINE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Approval Date : 2006-01-05

    Application Number : 77317

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    ELITE LABS INC

    U.S.A
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    ELITE LABS INC

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    RLD : No

    TE Code : AB

    ISRADIPINE

    Brand Name : ISRADIPINE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2.5MG

    Approval Date : 2006-04-24

    Application Number : 77169

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    04

    ELITE LABS INC

    U.S.A
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    RLD : No

    TE Code : AB

    ISRADIPINE

    Brand Name : ISRADIPINE

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG

    Approval Date : 2006-04-24

    Application Number : 77169

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    05

    SMITHKLINE BEECHAM

    United Kingdom
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    SMITHKLINE BEECHAM

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    RLD : Yes

    TE Code :

    ISRADIPINE

    Brand Name : DYNACIRC

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1990-12-20

    Application Number : 19546

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    06

    SMITHKLINE BEECHAM

    United Kingdom
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    SMITHKLINE BEECHAM

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    RLD : Yes

    TE Code :

    ISRADIPINE

    Brand Name : DYNACIRC

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1990-12-20

    Application Number : 19546

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    07

    GLAXOSMITHKLINE LLC

    United Kingdom
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    GLAXOSMITHKLINE LLC

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    RLD : Yes

    TE Code :

    ISRADIPINE

    Brand Name : DYNACIRC CR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1994-06-01

    Application Number : 20336

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    08

    GLAXOSMITHKLINE LLC

    United Kingdom
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    GLAXOSMITHKLINE LLC

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    RLD : Yes

    TE Code :

    ISRADIPINE

    Brand Name : DYNACIRC CR

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1994-06-01

    Application Number : 20336

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    09

    NORVIUM BIOSCIENCE

    Country
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    NORVIUM BIOSCIENCE

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    RLD : No

    TE Code :

    ISRADIPINE

    Brand Name : ISRADIPINE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 5MG

    Approval Date : 2015-11-27

    Application Number : 201067

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    NORVIUM BIOSCIENCE

    Country
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    NORVIUM BIOSCIENCE

    Country
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    RLD : No

    TE Code :

    ISRADIPINE

    Brand Name : ISRADIPINE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG

    Approval Date : 2015-11-27

    Application Number : 201067

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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