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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 (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019818Orig1s053ltr.pdf
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 (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019818s042ltr.pdf
10/26/2007 SUPPL-34 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019818s034ltr.pdf
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/05/2014 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf
09/25/2008 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf
10/26/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf
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