← FDA DRUG APPROVALS

FDA BLA · BLA021859

HYLENEX RECOMBINANT

hyaluronidase

Sponsor: HALOZYME THERAP

APPLICATION
BLA021859
TYPE
BLA
ORIGINAL APPROVAL
2005-12-02
LATEST ACTION
2024-01-12
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HYLENEX RECOMBINANTPrescription
HYALURONIDASE RECOMBINANT HUMAN 150 UNITS/ML · INJECTABLE · INJECTION

Approval history

2024-01-12Labeling · Supplement 31 · standard — Label ↗AP
2016-07-28Manufacturing (CMC) · Supplement 24 · priorityAP
2016-06-21Manufacturing (CMC) · Supplement 25 · priorityAP
2016-01-21Labeling · Supplement 23 · standard — Label ↗AP
2015-07-27Manufacturing (CMC) · Supplement 22 · priorityAP
2015-04-17Manufacturing (CMC) · Supplement 21 · priorityAP
2014-10-16Manufacturing (CMC) · Supplement 19 · priorityAP
2014-05-06Manufacturing (CMC) · Supplement 20 · priorityAP
2013-07-23Manufacturing (CMC) · Supplement 18 · priorityAP
2012-03-20Labeling · Supplement 15 · unknown — Letter ↗AP
2012-03-01Labeling · Supplement 9 · unknown — Letter ↗AP
2009-12-11Labeling · Supplement 6 · standard — Letter ↗AP
2008-10-01Labeling · Supplement 5 · standard — Label ↗AP
2006-06-09Labeling · Supplement 2 · standard — Letter ↗AP
2005-12-02Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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