avibactam / Ceftazidime Injection
- Brand(s)
- Avycaz
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Forest Laboratories, Inc (2015-09-08)
- Oldest Current Product
- 2014-12-26
- License(s)
- NDA
- RxNORM
- INJECTION\AVIBACTAM:CEFTAZIDIME
- FDAOB
- IV (INFUSION)\POWDER\AVIBACTAM SODIUM: CEFTAZIDIME\rdfq
- SPL Active
- INTRAVENOUS\POWDER, FOR SOLUTION\AVIBACTAM SODIUM: CEFTAZIDIME
- SPL Moiety
- INTRAVENOUS\POWDER, FOR SOLUTION\AVIBACTAM: CEFTAZIDIME ANHYDROUS
product(s) by strength(s)
avibactam 500 mg / ceftazidime 2000 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 004562700 | Avycaz | NDA | Forest Laboratories, Inc | 2014-12-26 | AVIBACTAM SODIUM, CEFTAZIDIME | INTRAVENOUS | POWDER, FOR SOLUTION | NDA206494 | d9c2803f-dc9c-4b19-b4a3-8303bc8c15fd |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA206494 | AVYCAZ | CEREXA INC | 2015-02-25 | p7112592, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE p8835455, SUBSTANCE p8969566 p8471025 p8178554, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE p7612087, SUBSTANCE | NDA206494_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA206494_001 | RX | AVIBACTAM SODIUM (EQ 0.5GM BASE), CEFTAZIDIME (2GM/VIAL) | POWDER | True | 2015-02-25 | AVYCAZ |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7112592 (view patent) | 2022-02-24 | NDA206494 |
| 2 | p7612087 (view patent) | 2026-11-12 | NDA206494 |
| 3 | p8178554 (view patent) | 2021-07-24 | NDA206494 |
| 4 | p8471025 (view patent) | 2031-08-12 | NDA206494 |
| 5 | p8835455 (view patent) | 2030-10-08 | NDA206494 |
| 6 | p8969566 (view patent) | 2032-06-15 | NDA206494 |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | d9c2803f-dc9c-4b19-b4a3-8303bc8c15fd (view SPL) | These highlights do not include all the information needed to use AVYCAZ safely and effectively. See full prescribing information for AVYCAZ.AVYCAZ (ceftazidime and avibactam) for injection, for intravenous useInitial U.S. Approval: 2015 | prescription | Human Prescription | Forest Laboratories, Inc | 2015-09-08 | 2 | 004562700 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII