← FDA DRUG APPROVALS

FDA NDA · NDA206494

AVYCAZ

ceftazidime, avibactam

Sponsor: ABBVIE

APPLICATION
NDA206494
TYPE
NDA
ORIGINAL APPROVAL
2015-02-25
LATEST ACTION
2025-04-25
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

AVYCAZ · ReferencePrescription
AVIBACTAM SODIUM EQ 0.5GM BASE, CEFTAZIDIME 2GM/VIAL · POWDER · INTRAVENOUS

Approval history

2025-04-25Labeling · Supplement 14 · standard — Letter ↗AP
2025-02-28Labeling · Supplement 13 · standard — Label ↗AP
2024-01-26Efficacy · Supplement 12 · priority — Label ↗AP
2022-12-20Efficacy · Supplement 11 · priority — Label ↗AP
2020-12-07Labeling · Supplement 7 · standard — Letter ↗AP
2019-03-14Efficacy · Supplement 6 · priority — Label ↗AP
2019-03-14Efficacy · Supplement 5 · priority — Label ↗AP
2018-02-01Efficacy · Supplement 4 · priority — Label ↗AP
2017-01-26Efficacy · Supplement 3 · priority — Label ↗AP
2016-06-22Efficacy · Supplement 2 · priority — Label ↗AP
2015-09-02Labeling · Supplement 1 · standard — Label ↗AP
2015-02-25Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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