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

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01 LEO PHARMA AS (1)

02 PFIZER (12)

03 PHARMACIA AND UPJOHN (2)

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01 INJECTABLE;INJECTION (4)

02 INJECTABLE;SUBCUTANEOUS (11)

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01 DISCN (6)

02 RX (9)

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01 FRAGMIN (12)

02 INNOHEP (1)

03 NORMIFLO (2)

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01 No (4)

02 Yes (11)

URL Supplier Web Content
INJECTABLE;INJECTION
10,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1997-05-23
20227
NORMIFLO
DISCN
Yes
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INJECTABLE;INJECTION
5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1997-05-23
20227
NORMIFLO
DISCN
Yes
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INJECTABLE;SUBCUTANEOUS
2,500IU/0.2ML (12,500IU/ML)
1994-12-22
20287
FRAGMIN
RX
Yes
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INJECTABLE;SUBCUTANEOUS
10,000IU/0.4ML (25,000IU/ML)
2007-05-01
20287
FRAGMIN
DISCN
No
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INJECTABLE;SUBCUTANEOUS
5,000IU/0.2ML (25,000IU/ML)
1996-03-18
20287
FRAGMIN
RX
Yes
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INJECTABLE;SUBCUTANEOUS
10,000IU/ML (10,000IU/ML)
1998-01-30
20287
FRAGMIN
RX
Yes
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INJECTABLE;SUBCUTANEOUS
7,500IU/0.3ML (25,000IU/ML)
2002-04-04
20287
FRAGMIN
RX
Yes
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INJECTABLE;SUBCUTANEOUS
95,000IU/3.8ML (25,000IU/ML)
2002-04-04
20287
FRAGMIN
RX
Yes
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INJECTABLE;SUBCUTANEOUS
95,000IU/9.5ML (10,000IU/ML)
2002-04-04
20287
FRAGMIN
DISCN
No
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INJECTABLE;INJECTION
7,500 IU/0.75ML
2002-04-04
20287
FRAGMIN
DISCN
No
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