Application 219491

Type: NDA
Sponsor: ENTASIS THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUZOLVENCE	ZOLIFLODACIN	FOR SUSPENSION;ORAL	3GM/PACKET	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N219491-001	NUZOLVENCE	ZOLIFLODACIN	3GM/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2025-12-12

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219491-001	9040528	2029-10-13	U-4369		2026-01-09
N219491-001	8658641	2030-06-20		Drug substance	2026-01-09
N219491-001	8889671	2034-01-21	U-4369	Drug substance	2026-01-09
N219491-001	9187495	2034-01-21	U-4369	Drug substance	2026-01-09
N219491-001	9540394	2034-01-21	U-4369		2026-01-09
N219491-001	9839641	2034-01-21	U-4369		2026-01-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219491-001	NCE	2030-12-12
N219491-001	GAIN	2035-12-12

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N219491-001	NUZOLVENCE	3GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2025-12-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219491-001	NUZOLVENCE	3GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2025-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219491-001	NUZOLVENCE	3GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2025-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219491-001	NUZOLVENCE	3GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2025-12-12	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	NUZOLVENCE	3GM/PACKET	FOR SUSPENSION / ORAL	RLD, RS	2025-12-12	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N219491-001	9040528	2029-10-13	U-4369		2026-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219491-001	8658641	2030-06-20		Drug substance	2026-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219491-001	8889671	2034-01-21	U-4369	Drug substance	2026-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219491-001	9187495	2034-01-21	U-4369	Drug substance	2026-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219491-001	9540394	2034-01-21	U-4369		2026-01-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219491-001	9839641	2034-01-21	U-4369		2026-01-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219491-001	9040528	2029-10-13	U-4369		2026-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219491-001	8658641	2030-06-20		Drug substance	2026-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219491-001	8889671	2034-01-21	U-4369	Drug substance	2026-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219491-001	9187495	2034-01-21	U-4369	Drug substance	2026-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219491-001	9540394	2034-01-21	U-4369		2026-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219491-001	9839641	2034-01-21	U-4369		2026-01-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219491-001	9040528	2029-10-13	U-4369		2026-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219491-001	8658641	2030-06-20		Drug substance	2026-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219491-001	8889671	2034-01-21	U-4369	Drug substance	2026-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219491-001	9187495	2034-01-21	U-4369	Drug substance	2026-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219491-001	9540394	2034-01-21	U-4369		2026-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219491-001	9839641	2034-01-21	U-4369		2026-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219491-001	9040528	2029-10-13	U-4369		2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219491-001	8658641	2030-06-20		Drug substance	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219491-001	8889671	2034-01-21	U-4369	Drug substance	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219491-001	9187495	2034-01-21	U-4369	Drug substance	2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219491-001	9540394	2034-01-21	U-4369		2026-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219491-001	9839641	2034-01-21	U-4369		2026-01-09	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	9040528	2029-10-13	U-4369		2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	8658641	2030-06-20		Drug substance	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	8889671	2034-01-21	U-4369	Drug substance	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	9187495	2034-01-21	U-4369	Drug substance	2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	9540394	2034-01-21	U-4369		2026-01-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	9839641	2034-01-21	U-4369		2026-01-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N219491-001	NCE	2030-12-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219491-001	GAIN	2035-12-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219491-001	NCE	2030-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219491-001	GAIN	2035-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219491-001	NCE	2030-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219491-001	GAIN	2035-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219491-001	NCE	2030-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219491-001	GAIN	2035-12-12	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	NCE	2030-12-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219491-001	GAIN	2035-12-12	`a50c72e98297…`

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
84733	ORIG	2026-01-12
84629	ORIG	2026-01-05
84416	ORIG	2025-12-15