Home Applications 220711 Application 220711
Type NDA
Sponsor BEONE MEDICINES USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BEQALZI SONROTOCLAX TABLET; ORAL 1MG No No 002 BEQALZI SONROTOCLAX TABLET; ORAL 5MG No No 003 BEQALZI SONROTOCLAX TABLET; ORAL 20MG No No 004 BEQALZI SONROTOCLAX TABLET; ORAL 80MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220711-001 BEQALZI SONROTOCLAX 1MG TABLET / ORAL RLD 2026-05-13 N220711-002 BEQALZI SONROTOCLAX 5MG TABLET / ORAL RLD 2026-05-13 N220711-003 BEQALZI SONROTOCLAX 20MG TABLET / ORAL RLD, RS 2026-05-13 N220711-004 BEQALZI SONROTOCLAX 80MG TABLET / ORAL RLD 2026-05-13
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 N220711-001 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 N220711-002 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 N220711-003 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 N220711-004 11420968 2039-04-29 Drug substance, Drug product 2026-05-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 N220711-001 BEQALZI 1MG TABLET / ORAL RLD 2026-05-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220711-002 BEQALZI 5MG TABLET / ORAL RLD 2026-05-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220711-003 BEQALZI 20MG TABLET / ORAL RLD, RS 2026-05-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220711-004 BEQALZI 80MG TABLET / ORAL RLD 2026-05-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220711-001 BEQALZI 1MG TABLET / ORAL RLD 2026-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220711-002 BEQALZI 5MG TABLET / ORAL RLD 2026-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220711-003 BEQALZI 20MG TABLET / ORAL RLD, RS 2026-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220711-004 BEQALZI 80MG TABLET / ORAL RLD 2026-05-13 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220711-001 BEQALZI 1MG TABLET / ORAL RLD 2026-05-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220711-002 BEQALZI 5MG TABLET / ORAL RLD 2026-05-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220711-003 BEQALZI 20MG TABLET / ORAL RLD, RS 2026-05-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220711-004 BEQALZI 80MG TABLET / ORAL RLD 2026-05-13 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 N220711-001 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220711-002 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220711-003 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220711-004 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220711-001 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220711-002 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220711-003 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220711-004 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220711-001 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220711-002 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220711-003 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220711-004 11420968 2039-04-29 Drug substance, Drug product 2026-05-28 a50c72e98297…
Observed Orange Book exclusivity history# 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 85919 ORIG 2026-05-15