Orange Book product · Brand (NDA)
FIRAZYR
ICATIBANT ACETATE
At a glance
Aug 25, 2011
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 25, 2011
15 yr ago
Today
Pharmaceutical detail
Active ingredient
ICATIBANT ACETATE
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Dosage form
INJECTABLE
Route
SUBCUTANEOUS
TE code
AP
Application
NDA 022150
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024ICATIBANT ACETATEGeneric (ANDA)
ANDA 213773 · ALEMBIC
- 2023ICATIBANT ACETATEGeneric (ANDA)
ANDA 213521 · EUGIA PHARMA
- 2021ICATIBANT ACETATEGeneric (ANDA)
ANDA 213222 · GLENMARK PHARMS LTD
- 2020ICATIBANT ACETATEGeneric (ANDA)
ANDA 212081 · NANG KUANG PHARM CO
- 2020ICATIBANT ACETATEGeneric (ANDA)
ANDA 213054 · CAPLIN
- 2020ICATIBANT ACETATEGeneric (ANDA)
ANDA 211501 · WILSHIRE PHARMS INC
- 2020ICATIBANT ACETATEGeneric (ANDA)
ANDA 212446 · CIPLA
- 2020ICATIBANT ACETATEGeneric (ANDA)
ANDA 208317 · FRESENIUS KABI USA
- 2020ICATIBANT ACETATEGeneric (ANDA)
ANDA 211021 · JIANGSU HANSOH PHARM
- 2019ICATIBANT ACETATEGeneric (ANDA)
ANDA 210118 · TEVA PHARMS USA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
