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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103411
Company: SIGMA TAU

Products on BLA 103411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONCASPAR	PEGASPARGASE	750IU/VIAL	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103411

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
03/13/2024	SUPPL-5207	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103411s5207lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103411Orig1s5207ltr.pdf
12/22/2022	SUPPL-5205	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103411s5205lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103411Orig1s5205ltr.pdf
11/02/2021	SUPPL-5201	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103411s5201lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103411Orig1s5201ltr.pdf
06/17/2020	SUPPL-5198	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103411s5198lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103411Orig1s5198ltr.pdf
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

Labels for BLA 103411

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/13/2024	SUPPL-5207	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103411s5207lbl.pdf
12/22/2022	SUPPL-5205	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103411s5205lbl.pdf
11/02/2021	SUPPL-5201	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103411s5201lbl.pdf
06/17/2020	SUPPL-5198	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103411s5198lbl.pdf
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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