Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103411
Company: SIGMA TAU
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONCASPAR PEGASPARGASE 750IU/VIAL VIAL Prescription 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
02/01/1994 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
01/03/2019 SUPPL-5196 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/193411s5196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103411Orig1s5196Ltr.pdf
10/07/2016 SUPPL-5188 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103411s5188lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103411Orig1s5188ltr.pdf
04/22/2014 SUPPL-5180 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103411s5180lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103411Orig1s5180ltr.pdf
03/23/2011 SUPPL-5126 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103411s5126lbl.pdf
07/24/2006 SUPPL-5052 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103411s5052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103411s5052ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/03/2019 SUPPL-5196 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/193411s5196lbl.pdf
10/07/2016 SUPPL-5188 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103411s5188lbl.pdf
04/22/2014 SUPPL-5180 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103411s5180lbl.pdf
03/23/2011 SUPPL-5126 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103411s5126lbl.pdf
07/24/2006 SUPPL-5052 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103411s5052lbl.pdf

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