Home Applications 022150 Application 022150
Type NDA
Sponsor SHIRE ORPHAN THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FIRAZYR ICATIBANT ACETATE INJECTABLE;SUBCUTANEOUS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022150-001 FIRAZYR ICATIBANT ACETATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2011-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022150-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N022150-001 FIRAZYR EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2011-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022150-001 FIRAZYR EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2011-08-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022150-001 FIRAZYR EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2011-08-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022150-001 FIRAZYR EQ 30MG BASE/3ML (EQ 10MG BASE/ML) INJECTABLE / SUBCUTANEOUS AP RLD, RS 2011-08-25 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022150-001 5648333 2019-07-15 U-1187 Drug substance, Drug product 2011-09-22 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022150-001 5648333 2019-07-15 U-1187 Drug substance, Drug product 2011-09-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022150-001 5648333 2019-07-15 U-1187 Drug substance, Drug product 2011-09-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022150-001 5648333 2019-07-15 U-1187 Drug substance, Drug product 2011-09-22 ea99ee380514…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Firazyr ICATIBANT ACETATE Takeda Pharmaceuticals America, Inc. ed6657ca-ab68-477a-9968-e12dc928b540 2025-07-07 Warnings, Adverse reactions Exact identifier application applno (NDA): 022150 application number: NDA022150 ndc (product): 54092-702
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54092-135 Icatibant Icatibant Takeda Pharmaceuticals America, Inc. NDA AUTHORIZED GENERIC Current 54092-135 Icatibant Icatibant Takeda Pharmaceuticals America, Inc. NDA AUTHORIZED GENERIC Current 54092-135 Firazyr icatibant acetate Shire US Manufacturing Inc. NDA AUTHORIZED GENERIC Current 54092-702 Firazyr icatibant acetate Shire US Manufacturing Inc. NDA Current 54092-702 Firazyr icatibant acetate Takeda Pharmaceuticals America, Inc. NDA Current 54092-702 Firazyr icatibant acetate Shire US Manufacturing Inc. NDA Current 54092-702 Firazyr icatibant acetate Takeda Pharmaceuticals America, Inc. NDA Current 54092-702 Firazyr icatibant acetate Takeda Pharmaceuticals America, Inc. NDA Current 54092-702 Firazyr icatibant acetate Shire US Manufacturing Inc. NDA Current