Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021716
Company: AKORN INC

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

Products on BLA 021716

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021716

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/25/2005	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021716lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021716ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2015	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021716s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021716Orig1s003ltr.pdf

Labels for BLA 021716

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2015	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021716s003lbl.pdf
10/25/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021716lbl.pdf