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

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    EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Bora Pharmaceuticals- Making success more certain.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    Axplora- The partner of choice for complex APIs.

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    Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    Dalteparin sodium

    ACTIVE PHARMA INGREDIENTS

    PRICE INFORMATION

    FINISHED DOSAGE FORMULATIONS

    DRUG PRODUCT COMPOSITIONS

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

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    01 1LEO PHARMA AS

    02 12PFIZER

    03 2PHARMACIA AND UPJOHN

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    01

    PHARMACIA AND UPJOHN

    U.S.A
    Discovery on Target
    Not Confirmed
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    PHARMACIA AND UPJOHN

    U.S.A
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code :

    ARDEPARIN SODIUM

    Brand Name : NORMIFLO

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 10,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1997-05-23

    Application Number : 20227

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    02

    PHARMACIA AND UPJOHN

    U.S.A
    Discovery on Target
    Not Confirmed
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    PHARMACIA AND UPJOHN

    U.S.A
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    Discovery on Target
    Not Confirmed
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    • EDQM
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    RLD : Yes

    TE Code :

    ARDEPARIN SODIUM

    Brand Name : NORMIFLO

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1997-05-23

    Application Number : 20227

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    03

    PFIZER

    U.S.A
    Discovery on Target
    Not Confirmed
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    PFIZER

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    Not Confirmed
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    RLD : Yes

    TE Code :

    DALTEPARIN SODIUM

    Brand Name : FRAGMIN

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 2,500IU/0.2ML (12,500IU/ML)

    Approval Date : 1994-12-22

    Application Number : 20287

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    04

    PFIZER

    U.S.A
    Discovery on Target
    Not Confirmed
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    PFIZER

    U.S.A
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    Not Confirmed
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    RLD : No

    TE Code :

    DALTEPARIN SODIUM

    Brand Name : FRAGMIN

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 10,000IU/0.4ML (25,000IU/ML)

    Approval Date : 2007-05-01

    Application Number : 20287

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    PFIZER

    U.S.A
    Discovery on Target
    Not Confirmed
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    PFIZER

    U.S.A
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code :

    DALTEPARIN SODIUM

    Brand Name : FRAGMIN

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 5,000IU/0.2ML (25,000IU/ML)

    Approval Date : 1996-03-18

    Application Number : 20287

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    06

    PFIZER

    U.S.A
    Discovery on Target
    Not Confirmed
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    PFIZER

    U.S.A
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    Discovery on Target
    Not Confirmed
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    RLD : Yes

    TE Code :

    DALTEPARIN SODIUM

    Brand Name : FRAGMIN

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 10,000IU/ML (10,000IU/ML)

    Approval Date : 1998-01-30

    Application Number : 20287

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    07

    PFIZER

    U.S.A
    Discovery on Target
    Not Confirmed
    arrow

    PFIZER

    U.S.A
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    Discovery on Target
    Not Confirmed
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    • EDQM
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    RLD : Yes

    TE Code :

    DALTEPARIN SODIUM

    Brand Name : FRAGMIN

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 7,500IU/0.3ML (25,000IU/ML)

    Approval Date : 2002-04-04

    Application Number : 20287

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    08

    PFIZER

    U.S.A
    Discovery on Target
    Not Confirmed
    arrow

    PFIZER

    U.S.A
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    Discovery on Target
    Not Confirmed
    • fda
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    RLD : Yes

    TE Code :

    DALTEPARIN SODIUM

    Brand Name : FRAGMIN

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 95,000IU/3.8ML (25,000IU/ML)

    Approval Date : 2002-04-04

    Application Number : 20287

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    09

    PFIZER

    U.S.A
    Discovery on Target
    Not Confirmed
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    PFIZER

    U.S.A
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    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
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    RLD : No

    TE Code :

    DALTEPARIN SODIUM

    Brand Name : FRAGMIN

    Dosage Form : INJECTABLE;SUBCUTANEOUS

    Dosage Strength : 95,000IU/9.5ML (10,000IU/ML)

    Approval Date : 2002-04-04

    Application Number : 20287

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    10

    PFIZER

    U.S.A
    Discovery on Target
    Not Confirmed
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    PFIZER

    U.S.A
    arrow
    Discovery on Target
    Not Confirmed
    • fda
    • EDQM
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    RLD : No

    TE Code :

    DALTEPARIN SODIUM

    Brand Name : FRAGMIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 7,500 IU/0.75ML

    Approval Date : 2002-04-04

    Application Number : 20287

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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