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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 021640
Company: BAUSCH AND LOMB

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

Products on BLA 021640

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VITRASE	HYALURONIDASE	6,200 UNITS/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
VITRASE	HYALURONIDASE	200 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 021640

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/05/2004	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640_vitrase_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021640_additional_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-640_Vitrase.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2024	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021640s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021640Orig1s028ltr.pdf
05/25/2018	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021640s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021640Orig1s025ltr.pdf
02/16/2015	SUPPL-24	Supplement		Label is not available on this site.
11/30/2015	SUPPL-23	Supplement		Label is not available on this site.
02/11/2014	SUPPL-22	Supplement		Label is not available on this site.
04/12/2012	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021640s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021640s016ltr.pdf
12/02/2004	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s002,003ltr.pdf
12/02/2004	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s002,003ltr.pdf
12/21/2004	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21640s001ltr.pdf

Labels for BLA 021640

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2024	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021640s028lbl.pdf
01/12/2024	SUPPL-28	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021640s028lbl.pdf
05/25/2018	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021640s025lbl.pdf
04/12/2012	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021640s016lbl.pdf
12/21/2004	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s001lbl.pdf
12/02/2004	SUPPL-3	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf
12/02/2004	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640s002,003lbl.pdf
05/05/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21640_vitrase_lbl.pdf

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