Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021846
Company: MICROBIX BIOSYSTEMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KINLYTIC UROKINASE 250,000 IU/VIAL INJECTABLE;INJECTION Discontinued None No No
KINLYTIC UROKINASE 9,000 IU/VIAL INJECTABLE;INJECTION Discontinued None No No
KINLYTIC UROKINASE 5,000 IU/VIAL INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/16/1978 ORIG-1 Approval N/A

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/2008 SUPPL-101 Supplement

Label is not available on this site.

10/30/2007 SUPPL-99 Supplement

Label is not available on this site.

05/18/2007 SUPPL-98 Supplement

Label is not available on this site.

06/30/1983 SUPPL-28 Supplement

Label is not available on this site.

10/14/1983 SUPPL-27 Supplement

Label is not available on this site.

01/22/1982 SUPPL-22 Supplement

Label is not available on this site.

09/23/1981 SUPPL-20 Supplement

Label is not available on this site.

04/20/1981 SUPPL-17 Supplement

Label is not available on this site.

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