Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 019818
Company: LEADIANT BIOSCI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAGEN PEGADEMASE BOVINE 250 UNITS/ML 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
03/21/1990 ORIG-1 Approval N/A; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2015 SUPPL-56 Supplement

Label is not available on this site.

07/17/2014 SUPPL-55 Supplement

Label is not available on this site.

06/05/2014 SUPPL-53 Supplement

Label is not available on this site.

03/04/2014 SUPPL-52 Supplement

Label is not available on this site.

12/17/2013 SUPPL-51 Supplement

Label is not available on this site.

01/10/2014 SUPPL-50 Supplement

Label is not available on this site.

10/15/2013 SUPPL-48 Supplement

Label is not available on this site.

10/07/2013 SUPPL-47 Supplement

Label is not available on this site.

01/15/2013 SUPPL-46 Supplement

Label is not available on this site.

09/25/2008 SUPPL-42 Supplement

Label is not available on this site.

10/26/2007 SUPPL-34 Supplement

Label is not available on this site.

04/15/2002 SUPPL-24 Supplement

Label is not available on this site.

08/17/2001 SUPPL-23 Supplement

Label is not available on this site.

09/16/1998 SUPPL-17 Supplement

Label is not available on this site.

12/06/1993 SUPPL-14 Supplement

Label is not available on this site.

06/16/1994 SUPPL-13 Supplement

Label is not available on this site.

08/11/1993 SUPPL-11 Supplement

Label is not available on this site.

11/10/1992 SUPPL-9 Supplement

Label is not available on this site.

12/28/1992 SUPPL-8 Supplement

Label is not available on this site.

03/09/1993 SUPPL-7 Supplement

Label is not available on this site.

04/22/1992 SUPPL-5 Supplement

Label is not available on this site.

04/13/1992 SUPPL-4 Supplement

Label is not available on this site.

09/27/1991 SUPPL-3 Supplement

Label is not available on this site.

06/10/1991 SUPPL-2 Supplement

Label is not available on this site.

11/28/1990 SUPPL-1 Supplement

Label is not available on this site.

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