Home Applications 206494 Application 206494
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AVYCAZ AVIBACTAM SODIUM; CEFTAZIDIME POWDER;IV (INFUSION) EQ 0.5GM BASE;2GM/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N206494-001 AVYCAZ AVIBACTAM SODIUM; CEFTAZIDIME EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206494-001 7112592 2026-01-07 U-2244 Drug substance, Drug product 2015-03-17 N206494-001 7112592 2026-01-07 U-2508 Drug substance, Drug product 2015-03-17 N206494-001 7112592 2026-01-07 U-282 Drug substance, Drug product 2015-03-17 N206494-001 7112592 2026-01-07 U-3818 Drug substance, Drug product 2015-03-17 N206494-001 7612087 2026-11-12 Drug product 2015-03-17 N206494-001 8835455 2030-10-08 Drug product 2015-03-17 N206494-001 8471025 2031-08-12 Drug substance 2015-03-17 N206494-001 8969566 2032-06-15 Drug substance 2015-03-17 N206494-001 9284314 2032-06-15 Drug substance 2017-02-24 N206494-001 9695122 2032-06-15 Drug substance 2017-08-08
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N206494-001 NPP 2027-01-26
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 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / IV (INFUSION) RLD, RS 2015-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / IV (INFUSION) RLD, RS 2015-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / IV (INFUSION) RLD, RS 2015-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / IV (INFUSION) RLD, RS 2015-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / IV (INFUSION) RLD, RS 2015-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / IV (INFUSION) RLD, RS 2015-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206494-001 AVYCAZ EQ 0.5GM BASE;2GM/VIAL POWDER / INTRAVENOUS RLD, RS 2015-02-25 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 11 · 412 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206494-001 7112592 2026-01-07 U-2508 Drug substance, Drug product 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 7112592 2026-01-07 U-2244 Drug substance, Drug product 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 7112592 2026-01-07 U-282 Drug substance, Drug product 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 7112592 2026-01-07 U-3818 Drug substance, Drug product 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 7612087 2026-11-12 Drug product 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 8835455 2030-10-08 Drug product 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 8471025 2031-08-12 Drug substance 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 8969566 2032-06-15 Drug substance 2015-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 9284314 2032-06-15 Drug substance 2017-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206494-001 9695122 2032-06-15 Drug substance 2017-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 7112592 2026-01-07 U-2508 Drug substance, Drug product 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 7112592 2026-01-07 U-2244 Drug substance, Drug product 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 7112592 2026-01-07 U-282 Drug substance, Drug product 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 7112592 2026-01-07 U-3818 Drug substance, Drug product 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 7612087 2026-11-12 Drug product 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 8835455 2030-10-08 Drug product 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 8471025 2031-08-12 Drug substance 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 8969566 2032-06-15 Drug substance 2015-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 9284314 2032-06-15 Drug substance 2017-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206494-001 9695122 2032-06-15 Drug substance 2017-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206494-001 7112592 2026-01-07 U-2508 Drug substance, Drug product 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 7112592 2026-01-07 U-2244 Drug substance, Drug product 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 7112592 2026-01-07 U-282 Drug substance, Drug product 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 7112592 2026-01-07 U-3818 Drug substance, Drug product 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 7612087 2026-11-12 Drug product 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 8835455 2030-10-08 Drug product 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 8471025 2031-08-12 Drug substance 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 8969566 2032-06-15 Drug substance 2015-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 9284314 2032-06-15 Drug substance 2017-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206494-001 9695122 2032-06-15 Drug substance 2017-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 7112592 2026-01-07 U-2508 Drug substance, Drug product 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 7112592 2026-01-07 U-2244 Drug substance, Drug product 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 7112592 2026-01-07 U-282 Drug substance, Drug product 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 7112592 2026-01-07 U-3818 Drug substance, Drug product 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 7612087 2026-11-12 Drug product 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 8835455 2030-10-08 Drug product 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 8471025 2031-08-12 Drug substance 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 8969566 2032-06-15 Drug substance 2015-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 9284314 2032-06-15 Drug substance 2017-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206494-001 9695122 2032-06-15 Drug substance 2017-08-08 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 102 observed states.
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.
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 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current 0456-2700 AVYCAZ ceftazidime, avibactam Allergan, Inc. NDA Current