Vitrase

BLA 21640, held by Bausch And Lomb. Hyaluronidase.

As of Nov 13, 2026, BLA 21640 (Vitrase), held by Bausch And Lomb, was first approved by FDA on May 5, 2004, with 9 approved supplements and 0 published complete response letters.

First approved: May 5, 2004
Review: Priority
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
May 5, 2004	Original applicationNew molecular entity · Priority review	Approved	Letter Label Letter Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Vitrase6,200 UNITS/VIAL · injectable;injection	Hyaluronidase	Discontinued
Vitrase200 UNITS/VIAL · injectable;injection	Hyaluronidase	Rx

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 12, 2024	Supplement 28Labeling · Standard review	Approved	Letter Label
May 25, 2018	Supplement 25Labeling · Standard review	Approved	Letter Label
Nov 30, 2015	Supplement 23Manufacturing · Priority review	Approved	None posted
Feb 16, 2015	Supplement 24Manufacturing · Priority review	Approved	None posted
Feb 11, 2014	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 12, 2012	Supplement 16Labeling	Approved	Letter Label
Dec 21, 2004	Supplement 1Labeling · Standard review	Approved	Letter Label
Dec 2, 2004	Supplement 3Manufacturing · Priority review	Approved	Letter Label
Dec 2, 2004	Supplement 2Labeling · Standard review	Approved	Letter Label
May 5, 2004	Original applicationNew molecular entity · Priority review	Approved	Letter Label Letter Review

Identifiers

Application: BLA 21640
Drugs@FDA: Overview at FDA
Company: Bausch & Lomb

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters