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    Approved Drug Products of Guardian Drug Company listed in the FDA Orange Book. Original Data : FDA Website

    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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    Guardian Drug Company

    EVENTS

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    DIGITAL CONTENT

    FINISHED DOSAGE FORMULATIONS

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    01 1ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

    02 1ESOMEPRAZOLE MAGNESIUM

    03 2GUAIFENESIN

    04 2IBUPROFEN

    05 1LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

    06 1LORATADINE

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    01

    Brand Name : FOAMCOAT

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    Brand Name : FOAMCOAT

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    RLD : No

    TE Code :

    ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

    Guardian Drug Company

    Dosage Form : TABLET, CHEWABLE; ORAL

    Proprietary Name : FOAMCOAT

    Dosage Strength : 80MG;20MG

    Approval Date : 1987-09-04

    Application Number : 71793

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    Brand Name : ESOMEPRAZOLE MAGNESI...

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    RLD : No

    TE Code :

    ESOMEPRAZOLE MAGNESIUM

    Guardian Drug Company

    Dosage Form : CAPSULE, DELAYED RELEASE; ORAL

    Proprietary Name : ESOMEPRAZOLE MAGNESIUM

    Dosage Strength : EQ 20MG BASE

    Approval Date : 2023-03-15

    Application Number : 216149

    RX/OTC/DISCN : OTC

    RLD : No

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    03

    Brand Name : GUAIFENESIN

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    Brand Name : GUAIFENESIN

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    RLD : No

    TE Code :

    GUAIFENESIN

    Guardian Drug Company

    Dosage Form : TABLET, EXTENDED RELEASE; ORAL

    Proprietary Name : GUAIFENESIN

    Dosage Strength : 600MG

    Approval Date : 2017-09-06

    Application Number : 209215

    RX/OTC/DISCN : OTC

    RLD : No

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    Brand Name : GUAIFENESIN

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    RLD : No

    TE Code :

    GUAIFENESIN

    Guardian Drug Company

    Dosage Form : TABLET, EXTENDED RELEASE; ORAL

    Proprietary Name : GUAIFENESIN

    Dosage Strength : 1.2GM

    Approval Date : 2017-09-06

    Application Number : 209215

    RX/OTC/DISCN : OTC

    RLD : No

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    05

    Brand Name : IBUPROFEN

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    RLD : No

    TE Code :

    IBUPROFEN

    Guardian Drug Company

    Dosage Form : SUSPENSION; ORAL

    Proprietary Name : IBUPROFEN

    Dosage Strength : 100MG/5ML

    Approval Date : 2018-08-17

    Application Number : 210149

    RX/OTC/DISCN : OTC

    RLD : No

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    Brand Name : IBUPROFEN

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    RLD : No

    TE Code :

    IBUPROFEN

    Guardian Drug Company

    Dosage Form : SUSPENSION/DROPS; ORAL

    Proprietary Name : IBUPROFEN

    Dosage Strength : 40MG/ML

    Approval Date : 2018-09-26

    Application Number : 210755

    RX/OTC/DISCN : OTC

    RLD : No

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    07

    Brand Name : LOPERAMIDE HYDROCHLO...

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    RLD : No

    TE Code :

    LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

    Guardian Drug Company

    Dosage Form : TABLET; ORAL

    Proprietary Name : LOPERAMIDE HYDROCHLORIDE...

    Dosage Strength : 2MG;125MG

    Approval Date : 2021-05-27

    Application Number : 214541

    RX/OTC/DISCN : OTC

    RLD : No

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    Brand Name : LORATADINE

    U.S.A
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    Brand Name : LORATADINE

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    RLD : No

    TE Code :

    LORATADINE

    Guardian Drug Company

    Dosage Form : TABLET; ORAL

    Proprietary Name : LORATADINE

    Dosage Strength : 10MG

    Approval Date : 2019-03-12

    Application Number : 207569

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

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