Active ingredient
Icatibant
9 finished FDA listings contain Icatibant as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ICATIBANT ACETATE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Subcutaneous
- Manufacturers / labelers
- 9
- Strengths listed
- 10 mg/ml · 30 mg/3ml
- Brand names in FDA listings
- Firazyr, Sajazir
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1148138
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022150 | TAKEDA PHARMS USA | 2011-08-25 | 1 |
| ANDA 210118 | TEVA PHARMS USA | 2019-07-15 | 1 |
| ANDA 211021 | JIANGSU HANSOH PHARM | 2020-03-09 | 1 |
| ANDA 208317 | FRESENIUS KABI USA | 2020-06-18 | 1 |
| ANDA 212446 | CIPLA | 2020-07-13 | 2 |
| ANDA 213521 | EUGIA PHARMA | 2023-08-14 | 1 |
| ANDA 213773 | ALEMBIC | 2024-06-14 | 2 |
Official labeling on DailyMed
- FIRAZYR (ICATIBANT ACETATE) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] · version 19 · 2025-07-17
- ICATIBANT INJECTION [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2025-07-03
- ICATIBANT INJECTION [ALEMBIC PHARMACEUTICALS INC.] · version 8 · 2025-07-03
- ICATIBANT INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.] · version 9 · 2025-02-12
- SAJAZIR (ICATIBANT) INJECTION [CYCLE PHARMACEUTICALS LTD-UK] · version 5 · 2024-05-24
- ICATIBANT INJECTION [CIPLA USA INC.] · version 6 · 2024-05-24
- ICATIBANT INJECTION, SOLUTION [EUGIA US LLC] · version 2 · 2024-05-21
- ICATIBANT INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 19 · 2024-04-26
- ICATIBANT (ICATIBANT) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC · version 4 · 2024-01-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.