Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022458
Company: PFIZER

• This Former NDA Was Deemed To Be a BLA on March 23, 2020.

Products on BLA 22458

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELELYSO	TALIGLUCERASE ALFA	200 UNITS/VIAL	POWDER;INTRAVENOUS	Prescription	None	No	No

Labels for BLA 022458

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/10/2024	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022458s031lbl.pdf
05/09/2023	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022458s030lbl.pdf
08/30/2022	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022458s029lbl.pdf
08/30/2022	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022458s029lbl.pdf
11/03/2020	SUPPL-24	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022458s024lbl.pdf
11/03/2020	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022458s024lbl.pdf
10/21/2019	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022458s023lbl.pdf
12/20/2016	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s013lbl.pdf
06/15/2016	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022458s012lbl.pdf
11/20/2015	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022458s007lbl.pdf
08/27/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf
08/27/2014	SUPPL-3	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s003s006lbl.pdf
05/14/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022458s002lbl.pdf
05/01/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf