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HYDASE

BLA

HYALURONIDASE | B021716 | AKORN INC

1 product0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 21716

351(a) ReferenceLicensedCDERInjection

Proper Name

hyaluronidase

Applicant

Akorn, Inc.

Approval Date

25-Oct-05

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150 UNITS/ML

▴

INJECTABLE;INJECTION | Approved: 2005-10-25 00:00:00

No patent or exclusivity listings for this strength.