Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021665
Company: AMPHASTAR PHARM

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

Products on BLA 21665

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPHADASE	HYALURONIDASE	150 UNITS/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Labels for BLA 021665

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/28/2024	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021665s007lbl.pdf
08/28/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021665s007lbl.pdf
06/28/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021665s005lbl.pdf
11/03/2005	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf
11/03/2005	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf
10/26/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf