← FDA DRUG APPROVALS

FDA BLA · BLA021640

VITRASE

Sponsor: BAUSCH AND LOMB

APPLICATION
BLA021640
TYPE
BLA
ORIGINAL APPROVAL
2004-05-05
LATEST ACTION
2024-01-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

VITRASEDiscontinued
HYALURONIDASE 6,200 UNITS/VIAL · INJECTABLE · INJECTION
VITRASEPrescription
HYALURONIDASE 200 UNITS/VIAL · INJECTABLE · INJECTION

Approval history

2024-01-12Labeling · Supplement 28 · standard — Letter ↗AP
2018-05-25Labeling · Supplement 25 · standard — Letter ↗AP
2015-11-30Manufacturing (CMC) · Supplement 23 · priorityAP
2015-02-16Manufacturing (CMC) · Supplement 24 · priorityAP
2014-02-11Manufacturing (CMC) · Supplement 22 · priorityAP
2012-04-12Labeling · Supplement 16 · unknown — Label ↗AP
2004-12-21Labeling · Supplement 1 · standard — Letter ↗AP
2004-12-02Labeling · Supplement 2 · standard — Label ↗AP
2004-12-02Manufacturing (CMC) · Supplement 3 · priority — Label ↗AP
2004-05-05Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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