An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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

Products on BLA 021665

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021665

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2004	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21665lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21665ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-665_Amphadase.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2015	SUPPL-6	Supplement		Label is not available on this site.
06/28/2012	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021665s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021665s005ltr.pdf
11/03/2005	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf
11/03/2005	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021665s001,002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021665s001,002ltr.pdf

Labels for BLA 021665

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

Top