Application 216352

Type: NDA
Sponsor: LUYE INNOMIND PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERZOFRI	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	39MG/0.25ML (39MG/0.25ML)	Yes	Yes
002	ERZOFRI	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	78MG/0.5ML (78MG/0.5ML)	Yes	Yes
003	ERZOFRI	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	117MG/0.75ML (117MG/0.75ML)	Yes	Yes
004	ERZOFRI	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	156MG/ML (156MG/ML)	Yes	Yes
005	ERZOFRI	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	234MG/1.5ML (156MG/ML)	Yes	Yes
006	ERZOFRI	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	351MG/2.25ML (156MG/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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216352-001	ERZOFRI	PALIPERIDONE PALMITATE	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-002	ERZOFRI	PALIPERIDONE PALMITATE	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-003	ERZOFRI	PALIPERIDONE PALMITATE	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-004	ERZOFRI	PALIPERIDONE PALMITATE	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-005	ERZOFRI	PALIPERIDONE PALMITATE	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26
N216352-006	ERZOFRI	PALIPERIDONE PALMITATE	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N216352-001	12128049	2038-10-26	U-3968	2024-10-31
N216352-001	12128049	2038-10-26	U-3969	2024-10-31
N216352-001	11666573	2039-09-24	U-3968	2024-07-30
N216352-001	11666573	2039-09-24	U-3969	2024-07-30
N216352-002	12128049	2038-10-26	U-3968	2024-10-31
N216352-002	12128049	2038-10-26	U-3969	2024-10-31
N216352-002	11666573	2039-09-24	U-3968	2024-07-30
N216352-002	11666573	2039-09-24	U-3969	2024-07-30
N216352-003	12128049	2038-10-26	U-3968	2024-10-31
N216352-003	12128049	2038-10-26	U-3969	2024-10-31
N216352-003	11666573	2039-09-24	U-3968	2024-07-30
N216352-003	11666573	2039-09-24	U-3969	2024-07-30
N216352-004	12128049	2038-10-26	U-3968	2024-10-31
N216352-004	12128049	2038-10-26	U-3969	2024-10-31
N216352-004	11666573	2039-09-24	U-3968	2024-07-30
N216352-004	11666573	2039-09-24	U-3969	2024-07-30
N216352-005	12128049	2038-10-26	U-3968	2024-10-31
N216352-005	12128049	2038-10-26	U-3969	2024-10-31
N216352-005	11666573	2039-09-24	U-3968	2024-07-30
N216352-005	11666573	2039-09-24	U-3969	2024-07-30
N216352-006	12128049	2038-10-26	U-3968	2024-10-31
N216352-006	12128049	2038-10-26	U-3969	2024-10-31
N216352-006	11666573	2039-09-24	U-3968	2024-07-30
N216352-006	11666573	2039-09-24	U-3969	2024-07-30

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.

Product history page 1 of 3 · 90 observed 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	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-005	ERZOFRI	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216352-006	ERZOFRI	351MG/2.25ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-001	ERZOFRI	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-002	ERZOFRI	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-003	ERZOFRI	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216352-004	ERZOFRI	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2024-07-26	`fd3edfee7708…`

Observed Orange Book patent history#

Patent history page 9 of 9 · 324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216352-006	12128049	2038-10-26	U-3969	2024-10-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216352-006	12128049	2038-10-26	U-3968	2024-10-31	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216352-006	11666573	2039-09-24	U-3969	2024-07-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216352-006	11666573	2039-09-24	U-3968	2024-07-30	`a50c72e98297…`

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
Erzofri extended-release	PALIPERIDONE PALMITATE	Shandong Luye Pharmaceutical Co., Ltd.	492bf9dd-868e-421a-92db-8cca8973aac1	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216352 application number: NDA216352

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
82434	ORIG	2025-06-02
81100	SUPPL	2025-02-06
81003	SUPPL	2025-02-05
79248	ORIG	2024-07-29
79241	ORIG	2024-07-29