Application 021716

Type: BLA
Sponsor: AKORN INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
021716	Hydase	hyaluronidase	351(a)	Disc	2026-08-01

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDASE	HYALURONIDASE	INJECTABLE;INJECTION	150 UNITS/ML	No	No

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HYLENEX Recombinant	HYALURONIDASE	Antares Pharma, Inc.	3023cc56-ed4b-4e87-b3a1-81b20943f658	2024-11-11	Warnings, Adverse reactions	Name fallback generic name: HYALURONIDASE
AMPHADASE	HYALURONIDASE	Amphastar Pharmaceuticals, Inc.	8396ea96-7cb5-4e26-87a4-90bca9c3c6dd	2024-02-01	Warnings, Adverse reactions	Name fallback generic name: HYALURONIDASE
HYALURONIDASE	HYALURONIDASE	HF Acquisition Co LLC, DBA HealthFirst	c3f1db01-58bf-2226-e053-2a95a90a8b33	2021-06-04	Warnings, Adverse reactions	Name fallback generic name: HYALURONIDASE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-560	Hydase	Hyaluronidase	Akorn, Inc.	NDA	Current
17478-560	Hydase	Hyaluronidase	Akorn, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62337	APPL	2020-03-25
42282	ORIG	2020-03-23
28450	SUPPL	2020-03-23
16249	SUPPL	2020-03-23
16248	ORIG	2020-03-23
6038	ORIG	2020-03-23