← FDA DRUG APPROVALS

FDA BLA · BLA021665

AMPHADASE

hyaluronidase

Sponsor: AMPHASTAR PHARM

APPLICATION
BLA021665
TYPE
BLA
ORIGINAL APPROVAL
2004-10-26
LATEST ACTION
2024-08-28
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AMPHADASEPrescription
HYALURONIDASE 150 UNITS/ML · INJECTABLE · INJECTION

Approval history

2024-08-28Labeling · Supplement 7 · standard — Letter ↗AP
2015-06-19Manufacturing (CMC) · Supplement 6 · priorityAP
2012-06-28Labeling · Supplement 5 · unknown — Label ↗AP
2005-11-03Manufacturing (CMC) · Supplement 2 · priority — Label ↗AP
2005-11-03Labeling · Supplement 1 · standard — Letter ↗AP
2004-10-26Type 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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