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 20772

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

Labels for BLA 020772

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2024	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020772s031lbl.pdf
07/24/2024	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020772s030lbl.pdf
05/25/2022	SUPPL-27	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020772Orig1s027Lbl.pdf