Application 213378

Type: NDA
Sponsor: ALKERMES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LYBALVI	OLANZAPINE; SAMIDORPHAN	TABLET; ORAL	5MG; 10MG	Yes	No
002	LYBALVI	OLANZAPINE; SAMIDORPHAN	TABLET; ORAL	10MG; 10MG	Yes	No
003	LYBALVI	OLANZAPINE; SAMIDORPHAN	TABLET; ORAL	15MG; 20MG	Yes	No
004	LYBALVI	OLANZAPINE; SAMIDORPHAN	TABLET; ORAL	20MG; 10MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N213378-001	LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28
N213378-002	LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28
N213378-003	LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28
N213378-004	LYBALVI	OLANZAPINE; SAMIDORPHAN L-MALATE	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28

Orange Book patents#

Current patent rows page 1 of 2 · 84 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213378-001	10716785	2031-08-23	U-3136		2021-06-25
N213378-001	10716785	2031-08-23	U-3137		2021-06-25
N213378-001	11185541	2031-08-23	U-3140		2021-12-22
N213378-001	11241425	2031-08-23	U-3137		2022-03-03
N213378-001	11351166	2031-08-23	U-3140		2022-07-11
N213378-001	11351166	2031-08-23	U-3141		2022-07-11
N213378-001	11793805	2031-08-23	U-3734		2023-11-13
N213378-001	12194035	2031-08-23	U-3141		2025-01-31
N213378-001	9126977	2031-08-23	U-3136	Drug product	2021-06-25
N213378-001	9126977	2031-08-23	U-3137	Drug product	2021-06-25
N213378-001	9517235	2031-08-23	U-3138		2021-06-25
N213378-001	9517235	2031-08-23	U-3139		2021-06-25
N213378-001	9119848	2031-08-30		Drug substance	2021-06-25
N213378-001	8778960	2032-02-13	U-3136		2021-06-25
N213378-001	8778960	2032-02-13	U-3137		2021-06-25
N213378-001	10300054	2033-05-31	U-3140	Drug product	2021-06-25
N213378-001	10300054	2033-05-31	U-3141	Drug product	2021-06-25
N213378-001	11707466	2041-11-12		Drug product	2023-08-23
N213378-001	11951111	2041-11-12	U-3886		2024-04-24
N213378-001	11951111	2041-11-12	U-3887		2024-04-24
N213378-001	12390474	2041-11-12		Drug product	2025-08-19
N213378-002	10716785	2031-08-23	U-3136		2021-06-25
N213378-002	10716785	2031-08-23	U-3137		2021-06-25
N213378-002	11185541	2031-08-23	U-3140		2021-12-22
N213378-002	11241425	2031-08-23	U-3137		2022-03-03
N213378-002	11351166	2031-08-23	U-3140		2022-07-11
N213378-002	11351166	2031-08-23	U-3141		2022-07-11
N213378-002	11793805	2031-08-23	U-3734		2023-11-13
N213378-002	12194035	2031-08-23	U-3141		2025-01-31
N213378-002	9126977	2031-08-23	U-3136	Drug product	2021-06-25
N213378-002	9126977	2031-08-23	U-3137	Drug product	2021-06-25
N213378-002	9517235	2031-08-23	U-3138		2021-06-25
N213378-002	9517235	2031-08-23	U-3139		2021-06-25
N213378-002	9119848	2031-08-30		Drug substance	2021-06-25
N213378-002	8778960	2032-02-13	U-3136		2021-06-25
N213378-002	8778960	2032-02-13	U-3137		2021-06-25
N213378-002	10300054	2033-05-31	U-3140	Drug product	2021-06-25
N213378-002	10300054	2033-05-31	U-3141	Drug product	2021-06-25
N213378-002	11707466	2041-11-12		Drug product	2023-08-23
N213378-002	11951111	2041-11-12	U-3886		2024-04-24
N213378-002	11951111	2041-11-12	U-3887		2024-04-24
N213378-002	12390474	2041-11-12		Drug product	2025-08-19
N213378-003	10716785	2031-08-23	U-3136		2021-06-25
N213378-003	10716785	2031-08-23	U-3137		2021-06-25
N213378-003	11185541	2031-08-23	U-3140		2021-12-22
N213378-003	11241425	2031-08-23	U-3137		2022-03-03
N213378-003	11351166	2031-08-23	U-3140		2022-07-11
N213378-003	11351166	2031-08-23	U-3141		2022-07-11
N213378-003	11793805	2031-08-23	U-3734		2023-11-13
N213378-003	12194035	2031-08-23	U-3141		2025-01-31
N213378-003	9126977	2031-08-23	U-3136	Drug product	2021-06-25
N213378-003	9126977	2031-08-23	U-3137	Drug product	2021-06-25
N213378-003	9517235	2031-08-23	U-3138		2021-06-25
N213378-003	9517235	2031-08-23	U-3139		2021-06-25
N213378-003	9119848	2031-08-30		Drug substance	2021-06-25
N213378-003	8778960	2032-02-13	U-3136		2021-06-25
N213378-003	8778960	2032-02-13	U-3137		2021-06-25
N213378-003	10300054	2033-05-31	U-3140	Drug product	2021-06-25
N213378-003	10300054	2033-05-31	U-3141	Drug product	2021-06-25
N213378-003	11707466	2041-11-12		Drug product	2023-08-23
N213378-003	11951111	2041-11-12	U-3886		2024-04-24
N213378-003	11951111	2041-11-12	U-3887		2024-04-24
N213378-003	12390474	2041-11-12		Drug product	2025-08-19
N213378-004	10716785	2031-08-23	U-3136		2021-06-25
N213378-004	10716785	2031-08-23	U-3137		2021-06-25
N213378-004	11185541	2031-08-23	U-3140		2021-12-22
N213378-004	11241425	2031-08-23	U-3137		2022-03-03
N213378-004	11351166	2031-08-23	U-3140		2022-07-11
N213378-004	11351166	2031-08-23	U-3141		2022-07-11
N213378-004	11793805	2031-08-23	U-3734		2023-11-13
N213378-004	12194035	2031-08-23	U-3141		2025-01-31
N213378-004	9126977	2031-08-23	U-3136	Drug product	2021-06-25
N213378-004	9126977	2031-08-23	U-3137	Drug product	2021-06-25
N213378-004	9517235	2031-08-23	U-3138		2021-06-25
N213378-004	9517235	2031-08-23	U-3139		2021-06-25
N213378-004	9119848	2031-08-30		Drug substance	2021-06-25
N213378-004	8778960	2032-02-13	U-3136		2021-06-25
N213378-004	8778960	2032-02-13	U-3137		2021-06-25
N213378-004	10300054	2033-05-31	U-3140	Drug product	2021-06-25
N213378-004	10300054	2033-05-31	U-3141	Drug product	2021-06-25

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213378-001	NCE	2026-05-28
N213378-002	NCE	2026-05-28
N213378-003	NCE	2026-05-28
N213378-004	NCE	2026-05-28

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 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-001	LYBALVI	5MG;EQ 10MG BASE	TABLET / ORAL	RLD, RS	2021-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-002	LYBALVI	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-003	LYBALVI	15MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-004	LYBALVI	20MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-05-28	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 62 · 2,444 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213378-001	10716785	2031-08-23	U-3136		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	10716785	2031-08-23	U-3137		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11185541	2031-08-23	U-3140		2021-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11241425	2031-08-23	U-3137		2022-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11351166	2031-08-23	U-3140		2022-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11351166	2031-08-23	U-3141		2022-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11793805	2031-08-23	U-3734		2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	12194035	2031-08-23	U-3141		2025-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9126977	2031-08-23	U-3136	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9126977	2031-08-23	U-3137	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9517235	2031-08-23	U-3139		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9517235	2031-08-23	U-3138		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	9119848	2031-08-30		Drug substance	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	8778960	2032-02-13	U-3136		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	8778960	2032-02-13	U-3137		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	10300054	2033-05-31	U-3140	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	10300054	2033-05-31	U-3141	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11707466	2041-11-12		Drug product	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11951111	2041-11-12	U-3886		2024-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	11951111	2041-11-12	U-3887		2024-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-001	12390474	2041-11-12		Drug product	2025-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	10716785	2031-08-23	U-3137		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	10716785	2031-08-23	U-3136		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11185541	2031-08-23	U-3140		2021-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11241425	2031-08-23	U-3137		2022-03-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11351166	2031-08-23	U-3140		2022-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11351166	2031-08-23	U-3141		2022-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11793805	2031-08-23	U-3734		2023-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	12194035	2031-08-23	U-3141		2025-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9126977	2031-08-23	U-3137	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9126977	2031-08-23	U-3136	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9517235	2031-08-23	U-3138		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9517235	2031-08-23	U-3139		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	9119848	2031-08-30		Drug substance	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	8778960	2032-02-13	U-3136		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	8778960	2032-02-13	U-3137		2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	10300054	2033-05-31	U-3141	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	10300054	2033-05-31	U-3140	Drug product	2021-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11707466	2041-11-12		Drug product	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	11951111	2041-11-12	U-3886		2024-04-24	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N213378-001	NCE	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-002	NCE	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-003	NCE	2026-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213378-004	NCE	2026-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213378-001	NCE	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-002	NCE	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-003	NCE	2026-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213378-004	NCE	2026-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-001	NCE	2026-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-002	NCE	2026-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-003	NCE	2026-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213378-004	NCE	2026-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213378-001	NCE	2026-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-002	NCE	2026-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-003	NCE	2026-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213378-004	NCE	2026-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-001	NCE	2026-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-002	NCE	2026-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-003	NCE	2026-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213378-004	NCE	2026-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-001	NCE	2026-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-002	NCE	2026-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-003	NCE	2026-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213378-004	NCE	2026-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-001	NCE	2026-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-002	NCE	2026-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-003	NCE	2026-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213378-004	NCE	2026-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-001	NCE	2026-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-002	NCE	2026-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-003	NCE	2026-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213378-004	NCE	2026-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-001	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-002	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-003	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213378-004	NCE	2026-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-001	NCE	2026-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-002	NCE	2026-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-003	NCE	2026-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213378-004	NCE	2026-05-28	`d8e5a09893c0…`

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
LYBALVI	OLANZAPINE AND SAMIDORPHAN L-MALATE	Alkermes, Inc.	32ffddd1-4e2b-45d9-9b36-bb730167ec80	2026-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213378 application number: NDA213378 ndc (product): 65757-654 ndc (product): 65757-652 ndc (product): 65757-653 ndc (product): 65757-651

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65757-651	LYBALVI	olanzapine and samidorphan L-malate	Alkermes, Inc.	NDA	Current
65757-651	LYBALVI	olanzapine and samidorphan L-malate	Alkermes, Inc.	NDA	Current
65757-652	LYBALVI	olanzapine and samidorphan L-malate	Alkermes, Inc.	NDA	Current
65757-652	LYBALVI	olanzapine and samidorphan L-malate	Alkermes, Inc.	NDA	Current
65757-653	LYBALVI	olanzapine and samidorphan L-malate	Alkermes, Inc.	NDA	Current
65757-653	LYBALVI	olanzapine and samidorphan L-malate	Alkermes, Inc.	NDA	Current
65757-654	LYBALVI	olanzapine and samidorphan L-malate	Alkermes, Inc.	NDA	Current
65757-654	LYBALVI	olanzapine and samidorphan L-malate	Alkermes, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84947	SUPPL	2026-02-05
84896	SUPPL	2026-02-03
81424	SUPPL	2025-03-04
81403	SUPPL	2025-03-03
81402	SUPPL	2025-03-03
81162	SUPPL	2025-02-07
81027	SUPPL	2025-02-05
77362	SUPPL	2024-01-31
77360	SUPPL	2024-01-31
75566	SUPPL	2023-09-26
75565	SUPPL	2023-09-26
67904	ORIG	2021-06-25
67903	ORIG	2021-06-25
67641	ORIG	2021-06-01
67640	ORIG	2021-06-01
67639	ORIG	2021-06-01
67638	ORIG	2021-06-01
67637	ORIG	2021-06-01