Home Applications 219491 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 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 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 Product TE source text RLD / RS Approval date Source SHA-256 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 2026-09-14 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# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NUZOLVENCE ZOLIFLODACIN La Jolla Pharmaceutical Company 4beda35a-21b0-4b34-84ea-be6ea8cae50f 2025-12-22 Warnings, Adverse reactions Exact identifier application applno (NDA): 219491 application number: NDA219491
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