Application 218711

Type: NDA
Sponsor: ZHUHAI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BEIZRAY	DOCETAXEL	SOLUTION;INTRAVENOUS	80MG/4ML (20MG/ML)	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N218711-001	BEIZRAY	DOCETAXEL	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2024-10-23
N218711-002	BEIZRAY	DOCETAXEL	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-12-10

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13
N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13
N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13
N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13
N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-4027	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-4028	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13
N218711-001	12090134	2036-05-16	U-946	Drug product	2024-11-13
N218711-001	12090135	2036-05-16		Drug product	2024-11-13
N218711-002	11419842	2036-05-16	U-4027	Drug product	2026-09-10
N218711-002	11419842	2036-05-16	U-4028	Drug product	2026-09-10
N218711-002	11419842	2036-05-16	U-881	Drug product	2026-09-10
N218711-002	11419842	2036-05-16	U-937	Drug product	2026-09-10
N218711-002	11419842	2036-05-16	U-946	Drug product	2026-09-10
N218711-002	12090134	2036-05-16	U-4027	Drug product	2026-09-10
N218711-002	12090134	2036-05-16	U-4028	Drug product	2026-09-10
N218711-002	12090134	2036-05-16	U-881	Drug product	2026-09-10
N218711-002	12090134	2036-05-16	U-937	Drug product	2026-09-10
N218711-002	12090134	2036-05-16	U-946	Drug product	2026-09-10
N218711-002	12090135	2036-05-16		Drug product	2026-09-10

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	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	BEIZRAY	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-12-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-002	BEIZRAY	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-12-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218711-002	BEIZRAY	20MG/ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD	2024-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218711-001	BEIZRAY	80MG/4ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-10-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 132 observed states.

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	N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	12090134	2036-05-16	U-946	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	12090134	2036-05-16	U-4027	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	12090134	2036-05-16	U-4028	Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-001	12090135	2036-05-16		Drug product	2024-11-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	11419842	2036-05-16	U-946	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	11419842	2036-05-16	U-881	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	11419842	2036-05-16	U-937	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	11419842	2036-05-16	U-4027	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	11419842	2036-05-16	U-4028	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	12090134	2036-05-16	U-946	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	12090134	2036-05-16	U-881	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	12090134	2036-05-16	U-937	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	12090134	2036-05-16	U-4027	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	12090134	2036-05-16	U-4028	Drug product	2026-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218711-002	12090135	2036-05-16		Drug product	2026-09-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	12090134	2036-05-16	U-946	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	12090134	2036-05-16	U-4027	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	12090134	2036-05-16	U-4028	Drug product	2024-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218711-001	12090135	2036-05-16		Drug product	2024-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218711-001	11419842	2036-05-16	U-881	Drug product	2024-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218711-001	11419842	2036-05-16	U-937	Drug product	2024-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218711-001	11419842	2036-05-16	U-946	Drug product	2024-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218711-001	11419842	2036-05-16	U-4027	Drug product	2024-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218711-001	11419842	2036-05-16	U-4028	Drug product	2024-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218711-001	12090134	2036-05-16	U-881	Drug product	2024-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218711-001	12090134	2036-05-16	U-937	Drug product	2024-11-13	`caaa826d4ba7…`

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
BEIZRAY	DOCETAXEL	Zydus Pharmaceuticals USA Inc.	8fb7d980-d6c7-468b-a9f0-adff16101a4b	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218711 application number: NDA218711

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
82966	ORIG	2025-07-29
82083	SUPPL	2025-05-01
79980	ORIG	2024-10-25
79979	ORIG	2024-10-25