Amphadase

BLA 21665, held by Amphastar Pharm. Hyaluronidase.

As of Nov 13, 2026, BLA 21665 (Amphadase), held by Amphastar Pharm, was first approved by FDA on Oct 26, 2004, with 5 approved supplements and 0 published complete response letters.

First approved: Oct 26, 2004
Review: Priority
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Amphadase is an endoglycosidase indicated as an adjuvant:

in subcutaneous fluid administration for achieving hydration
to increase absorption and dispersion of other injected drugs
in subcutaneous urography for improving resorption of radiopaque agents 1.1 Subcutaneous Fluid Administration Amphadase is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispersion and Absorption of Injected Drugs Amphadase is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs. 1.3 Subcutaneous Urography Amphadase is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Oct 26, 2004	Original applicationNew molecular entity · Priority review	Approved	Label Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amphadase150 UNITS/ML · injectable;injection	Hyaluronidase	Rx

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 28, 2024	Supplement 7Labeling · Standard review	Approved	Label Letter
Jun 19, 2015	Supplement 6Manufacturing · Priority review	Approved	None posted
Jun 28, 2012	Supplement 5Labeling	Approved	Letter Label
Nov 3, 2005	Supplement 1Labeling · Standard review	Approved	Letter Label
Nov 3, 2005	Supplement 2Manufacturing · Priority review	Approved	Label Letter
Oct 26, 2004	Original applicationNew molecular entity · Priority review	Approved	Label Letter Review

Identifiers

Application: BLA 21665
Drugs@FDA: Overview at FDA
Company: Amphastar Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters