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    Approved Drug Products containing Alprostadil Prostoglandin E1 listed in the FDA Orange Book. Original Data : FDA Website

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Alprostadil Prostoglandin E1

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    01 7ENDO OPERATIONS

    02 1HIKMA

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    PFIZER

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    RLD : Yes

    TE Code : AP

    ALPROSTADIL

    Brand Name : PROSTIN VR PEDIATRIC

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.5MG/ML

    Approval Date : 1982-01-01

    Application Number : 18484

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    02

    PFIZER

    U.S.A
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    RLD : Yes

    TE Code : AP

    ALPROSTADIL

    Brand Name : CAVERJECT

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.01MG/VIAL

    Approval Date : 1995-07-06

    Application Number : 20379

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    03

    PFIZER

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    RLD : Yes

    TE Code : AP

    ALPROSTADIL

    Brand Name : CAVERJECT

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.02MG/VIAL

    Approval Date : 1995-07-06

    Application Number : 20379

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    04

    PFIZER

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    RLD : Yes

    TE Code :

    ALPROSTADIL

    Brand Name : CAVERJECT

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.005MG/VIAL

    Approval Date : 1996-06-27

    Application Number : 20379

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    05

    PFIZER

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    RLD : Yes

    TE Code : AP

    ALPROSTADIL

    Brand Name : CAVERJECT

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.04MG/VIAL

    Approval Date : 1997-05-19

    Application Number : 20379

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    06

    ENDO OPERATIONS

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    RLD : No

    TE Code :

    ALPROSTADIL

    Brand Name : EDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.005MG/VIAL

    Approval Date : 1997-06-12

    Application Number : 20649

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    ENDO OPERATIONS

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    RLD : Yes

    TE Code : AP

    ALPROSTADIL

    Brand Name : EDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.01MG/VIAL

    Approval Date : 1997-06-12

    Application Number : 20649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    08

    ENDO OPERATIONS

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    BioProcess International
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    RLD : Yes

    TE Code : AP

    ALPROSTADIL

    Brand Name : EDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.02MG/VIAL

    Approval Date : 1997-06-12

    Application Number : 20649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    09

    ENDO OPERATIONS

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    BioProcess International
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    ENDO OPERATIONS

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    BioProcess International
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    RLD : Yes

    TE Code : AP

    ALPROSTADIL

    Brand Name : EDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.04MG/VIAL

    Approval Date : 1997-06-12

    Application Number : 20649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AP

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    10

    ENDO OPERATIONS

    Country
    BioProcess International
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    ENDO OPERATIONS

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    BioProcess International
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    RLD : Yes

    TE Code :

    ALPROSTADIL

    Brand Name : EDEX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 0.01MG/VIAL

    Approval Date : 1998-07-30

    Application Number : 20649

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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