Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020772
Company: QOL MEDCL

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

Products on BLA 020772

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUCRAID	SACROSIDASE	8,500 IU/ML	SOLUTION;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 020772

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/1998	ORIG-1	Approval		N/A; Orphan	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20772ap_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20772.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2022	SUPPL-27	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020772Orig1s027Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020772Orig1s027ltr.pdf
09/21/2015	SUPPL-20	Supplement		Label is not available on this site.
02/16/2015	SUPPL-19	Supplement		Label is not available on this site.
12/02/2014	SUPPL-17	Supplement		Label is not available on this site.
11/07/2014	SUPPL-15	Supplement		Label is not available on this site.
05/28/2013	SUPPL-13	Supplement		Label is not available on this site.
12/09/2010	SUPPL-11	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020772s011ltr.pdf
06/15/2011	SUPPL-8	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020772s008ltr.pdf
11/20/2008	SUPPL-7	Supplement		Label is not available on this site.
11/20/2008	SUPPL-6	Supplement		Label is not available on this site.
11/20/2008	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020772s005ltr.pdf
02/20/2008	SUPPL-4	Supplement		Label is not available on this site.
11/03/2006	SUPPL-2	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020772s002ltr.pdf

Labels for BLA 020772

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2022	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020772Orig1s027Lbl.pdf