Home Applications 021665 Application 021665
Type BLA
Sponsor AMPHASTAR PHARM Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 021665 Amphadase hyaluronidase 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMPHADASE 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 · 1 matching rows.
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 0548-9090 AMPHADASE hyaluronidase Amphastar Pharmaceuticals, Inc. NDA Current 0548-9090 AMPHADASE hyaluronidase Amphastar Pharmaceuticals, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 79513 SUPPL 2024-09-02 79501 SUPPL 2024-08-29 62336 APPL 2020-03-25 42262 ORIG 2020-03-23 37427 SUPPL 2020-03-23 37426 SUPPL 2020-03-23 28337 SUPPL 2020-03-23 28336 SUPPL 2020-03-23 28335 ORIG 2020-03-23 15947 SUPPL 2020-03-23 15946 ORIG 2020-03-23 5949 SUPPL 2020-03-23