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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020521
Company: ONY

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

Products on BLA 020521

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INFASURF PRESERVATIVE FREE	CALFACTANT	35MG/ML	SUSPENSION;INTRATRACHEAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 020521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/1998	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20521ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20521_Infasurf.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2024	SUPPL-38	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020521s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020521Orig1s038ltr.pdf
03/09/2015	SUPPL-29	Supplement		Label is not available on this site.
03/09/2015	SUPPL-28	Supplement		Label is not available on this site.
03/11/2014	SUPPL-27	Supplement		Label is not available on this site.
10/18/2013	SUPPL-26	Supplement		Label is not available on this site.
12/23/2013	SUPPL-25	Supplement		Label is not available on this site.
07/01/2011	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020521s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020521s024ltr.pdf
12/10/2009	SUPPL-21	Supplement		Label is not available on this site.
09/13/2002	SUPPL-11	Supplement		Label is not available on this site.
02/19/2002	SUPPL-10	Supplement		Label is not available on this site.
11/20/2001	SUPPL-9	Supplement		Label is not available on this site.
12/12/2002	SUPPL-8	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20521scm008ltr.pdf
04/18/2002	SUPPL-7	Supplement		Label is not available on this site.
04/18/2002	SUPPL-6	Supplement		Label is not available on this site.
05/18/2000	SUPPL-4	Supplement		Label is not available on this site.
02/23/2000	SUPPL-3	Supplement		Label is not available on this site.
10/14/1999	SUPPL-2	Supplement		Label is not available on this site.
03/17/1999	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 020521

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2024	SUPPL-38	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020521s038lbl.pdf
08/23/2024	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020521s038lbl.pdf
07/01/2011	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020521s024lbl.pdf
07/01/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf

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