Drugs
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Urokinase Product Approval Information - New Drug Application 10/10/02
Product name: Urokinase (Abbokinase)
Manufacturer: Abbott Laboratories, Abbott Park, IL
Intended Use: for adults for the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments, and for the lysis of pulmonary emboli accompanied by unstable hemodynamics, i.e., failure to maintain blood pressure without supportive measures
Approval Date: 10/10/2002
Type of submission: New Drug application supplement
Approval Letter - (PDF)
Label - (PDF)
Other Information on Urokinase
- Letter to Abbott Laboratories Concerning Serious Manufacturing Deficiencies with Abbokinase (PDF)-7/14/1999
- Warning Letter - Abbokinase (Urokinase) (PDF) - 3/19/1999
- Update on Abbokinase (Urokinase) - 3/16/1999 - Updated information is provided in the 3/22/1999 Update on Abbokinase Information Sheet
- Update on Abbokinase (Urokinase) - 3/12/1999
- Dear Healthcare Provider: Important Drug Warning: Safety information regarding the use of Abbokinase (Urokinase) (PDF) - 1/25/1999 - Updated information is provided in the 3/16/1999 Update on Abbokinase Information Sheet
- Difficulties in Obtaining Sufficient Amounts of Urokinase (Abbokinase) - 12/11/1998 - Updated information is provided in the 1/25/1999 Dear Healthcare Provider letter
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