Home Applications 216974 Application 216974
Type NDA
Sponsor ENTASIS THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XACDURO (COPACKAGED) DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM POWDER;INTRAVENOUS EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N216974-001 XACDURO (COPACKAGED) DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216974-001 NCE 2028-05-23 N216974-001 GAIN 2033-05-23
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.
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 2026-09-14 22:38:34 2026-08 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-24 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216974-001 XACDURO (COPACKAGED) EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 92 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216974-001 9309245 2033-04-02 Drug substance 2023-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216974-001 9623014 2033-04-02 U-2840 2023-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216974-001 10376499 2035-11-17 U-2840 Drug product 2023-06-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216974-001 9968593 2035-11-17 U-2840 Drug product 2023-06-22 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 74567 ORIG 2023-06-21 74373 ORIG 2023-05-25 74365 ORIG 2023-05-24