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01 1LEO PHARMA AS

02 12PFIZER

03 2PHARMACIA AND UPJOHN

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PharmaCompass

01

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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Dosage Strength : 10,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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Dosage Strength : 5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

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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