Application 022363

Type: NDA
Sponsor: KOWA CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIVALO	PITAVASTATIN CALCIUM	TABLET;ORAL	EQ 1MG BASE	Yes	No
002	LIVALO	PITAVASTATIN CALCIUM	TABLET;ORAL	EQ 2MG BASE	Yes	No
003	LIVALO	PITAVASTATIN CALCIUM	TABLET;ORAL	EQ 4MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022363-001	LIVALO	PITAVASTATIN CALCIUM	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03
N022363-002	LIVALO	PITAVASTATIN CALCIUM	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03
N022363-003	LIVALO	PITAVASTATIN CALCIUM	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022363-001	AB
N022363-002	AB
N022363-003	AB

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 · 129 observed 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	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022363-002	LIVALO	EQ 2MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022363-003	LIVALO	EQ 4MG BASE	TABLET / ORAL	AB	RLD, RS	2009-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022363-001	LIVALO	EQ 1MG BASE	TABLET / ORAL	AB	RLD	2009-08-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022363-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022363-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022363-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022363-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022363-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022363-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022363-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022363-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022363-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022363-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022363-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022363-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022363-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022363-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022363-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022363-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022363-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022363-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022363-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022363-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022363-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022363-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022363-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022363-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022363-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022363-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022363-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022363-001	AB	1	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 465 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-001	8557993	2024-02-02		Drug product	2013-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-001	7022713	2024-02-19	U-998			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-001	8557993*PED	2024-08-02		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-001	7022713*PED	2024-08-19		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-002	8557993	2024-02-02		Drug product	2013-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-002	7022713	2024-02-19	U-998			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-002	8557993*PED	2024-08-02		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-002	7022713*PED	2024-08-19		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-003	8557993	2024-02-02		Drug product	2013-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-003	7022713	2024-02-19	U-998			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-003	8557993*PED	2024-08-02		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022363-003	7022713*PED	2024-08-19		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-001	8557993	2024-02-02		Drug product	2013-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-001	7022713	2024-02-19	U-998			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-001	8557993*PED	2024-08-02		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-001	7022713*PED	2024-08-19		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-002	8557993	2024-02-02		Drug product	2013-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-002	7022713	2024-02-19	U-998			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-002	8557993*PED	2024-08-02		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-002	7022713*PED	2024-08-19		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-003	8557993	2024-02-02		Drug product	2013-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-003	7022713	2024-02-19	U-998			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-003	8557993*PED	2024-08-02		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022363-003	7022713*PED	2024-08-19		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-001	8557993	2024-02-02		Drug product	2013-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-001	7022713	2024-02-19	U-998			`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-001	8557993*PED	2024-08-02		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-001	7022713*PED	2024-08-19		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-002	8557993	2024-02-02		Drug product	2013-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-002	7022713	2024-02-19	U-998			`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-002	8557993*PED	2024-08-02		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-002	7022713*PED	2024-08-19		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-003	8557993	2024-02-02		Drug product	2013-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-003	7022713	2024-02-19	U-998			`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-003	8557993*PED	2024-08-02		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022363-003	7022713*PED	2024-08-19		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-001	8557993	2024-02-02		Drug product	2013-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-001	7022713	2024-02-19	U-998			`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-001	8557993*PED	2024-08-02		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022363-001	7022713*PED	2024-08-19		Pediatric extension		`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022363-001	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022363-001	PED	2022-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022363-002	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022363-002	PED	2022-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022363-003	NPP	2022-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022363-003	PED	2022-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022363-001	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022363-001	PED	2022-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022363-002	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022363-002	PED	2022-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022363-003	NPP	2022-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022363-003	PED	2022-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022363-001	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022363-001	PED	2022-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022363-002	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022363-002	PED	2022-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022363-003	NPP	2022-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022363-003	PED	2022-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022363-001	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022363-001	PED	2022-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022363-002	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022363-002	PED	2022-11-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022363-003	NPP	2022-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022363-003	PED	2022-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022363-001	NPP	2022-05-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022363-001	PED	2022-11-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022363-002	NPP	2022-05-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022363-002	PED	2022-11-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022363-003	NPP	2022-05-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022363-003	PED	2022-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022363-001	NPP	2022-05-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022363-001	PED	2022-11-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022363-002	NPP	2022-05-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022363-002	PED	2022-11-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022363-003	NPP	2022-05-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022363-003	PED	2022-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022363-001	NPP	2022-05-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022363-001	PED	2022-11-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022363-002	NPP	2022-05-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022363-002	PED	2022-11-16	`87673890dc5c…`

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
Livalo	PITAVASTATIN CALCIUM	Kowa Pharmaceuticals America, Inc.	44dcbf97-99ec-427c-ba50-207e0069d6d2	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022363 application number: NDA022363 ndc (product): 66869-204 ndc (product): 66869-104 ndc (product): 66869-404

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66869-104	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-104	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-104	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-204	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-204	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-204	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-404	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-404	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-404	Livalo	pitavastatin calcium	Kowa Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77844	SUPPL	2024-03-15
77837	SUPPL	2024-03-15
72596	SUPPL	2022-11-10
72595	SUPPL	2022-11-10
64731	SUPPL	2020-09-29
64704	SUPPL	2020-09-28
60614	SUPPL	2019-10-22
60610	SUPPL	2019-10-21
58820	SUPPL	2019-05-21
58772	SUPPL	2019-05-17
45918	SUPPL	2016-11-22
45936	SUPPL	2016-11-21
38627	SUPPL	2013-10-18
29657	SUPPL	2013-10-18
38626	SUPPL	2012-11-06
29656	SUPPL	2012-11-06
22004	SUPPL	2012-04-24
22003	SUPPL	2012-03-30
38625	SUPPL	2012-02-28
29655	SUPPL	2012-02-28
17297	SUPPL	2012-02-28
7297	SUPPL	2012-02-28
29654	SUPPL	2011-08-05
17296	SUPPL	2011-08-05
29653	SUPPL	2011-06-27
17295	SUPPL	2011-06-16
7296	SUPPL	2010-06-08
42500	ORIG	2009-11-23
38624	ORIG	2009-08-26
7295	ORIG	2009-08-26
64049	ORIG	1900-01-01
64048	ORIG	1900-01-01
63238	SUPPL	1900-01-01
63237	SUPPL	1900-01-01
63236	SUPPL	1900-01-01
63235	SUPPL	1900-01-01