Application 206406

Type: NDA
Sponsor: VELOXIS PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENVARSUS XR	TACROLIMUS	TABLET, EXTENDED RELEASE;ORAL	EQ 0.75MG BASE	Yes	No
002	ENVARSUS XR	TACROLIMUS	TABLET, EXTENDED RELEASE;ORAL	EQ 1MG BASE	Yes	No
003	ENVARSUS XR	TACROLIMUS	TABLET, EXTENDED RELEASE;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	RLD / RS	Approval date
N206406-001	ENVARSUS XR	TACROLIMUS	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10
N206406-002	ENVARSUS XR	TACROLIMUS	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10
N206406-003	ENVARSUS XR	TACROLIMUS	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10

Orange Book patents#

Current patent rows page 1 of 1 · 45 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206406-001	10166190	2028-05-30		Drug product	2019-02-14
N206406-001	10864199	2028-05-30	U-2677		2021-01-06
N206406-001	10864199	2028-05-30	U-2678		2021-01-06
N206406-001	11110081	2028-05-30	U-2678		2021-09-16
N206406-001	11123331	2028-05-30	U-2677		2021-09-28
N206406-001	11419823	2028-05-30		Drug product	2022-08-24
N206406-001	12083103	2028-05-30	U-2678		2024-09-12
N206406-001	12403095	2028-05-30		Drug product	2025-09-08
N206406-001	9549918	2028-05-30		Drug product	2017-05-02
N206406-001	8664239	2028-08-30	U-1752		2015-08-24
N206406-001	8664239	2028-08-30	U-2677		2015-08-24
N206406-001	8664239	2028-08-30	U-2678		2015-08-24
N206406-001	8685998	2028-08-30	U-1752	Drug product	2015-08-24
N206406-001	8685998	2028-08-30	U-2677	Drug product	2015-08-24
N206406-001	8685998	2028-08-30	U-2678	Drug product	2015-08-24
N206406-002	10166190	2028-05-30		Drug product	2019-02-14
N206406-002	10864199	2028-05-30	U-2677		2021-01-06
N206406-002	10864199	2028-05-30	U-2678		2021-01-06
N206406-002	11110081	2028-05-30	U-2678		2021-09-16
N206406-002	11123331	2028-05-30	U-2677		2021-09-28
N206406-002	11419823	2028-05-30		Drug product	2022-08-24
N206406-002	12083103	2028-05-30	U-2678		2024-09-12
N206406-002	12403095	2028-05-30		Drug product	2025-09-08
N206406-002	9549918	2028-05-30		Drug product	2017-05-02
N206406-002	8664239	2028-08-30	U-1752		2015-08-24
N206406-002	8664239	2028-08-30	U-2677		2015-08-24
N206406-002	8664239	2028-08-30	U-2678		2015-08-24
N206406-002	8685998	2028-08-30	U-1752	Drug product	2015-08-24
N206406-002	8685998	2028-08-30	U-2677	Drug product	2015-08-24
N206406-002	8685998	2028-08-30	U-2678	Drug product	2015-08-24
N206406-003	10166190	2028-05-30		Drug product	2019-02-14
N206406-003	10864199	2028-05-30	U-2677		2021-01-06
N206406-003	10864199	2028-05-30	U-2678		2021-01-06
N206406-003	11110081	2028-05-30	U-2678		2021-09-16
N206406-003	11123331	2028-05-30	U-2677		2021-09-28
N206406-003	11419823	2028-05-30		Drug product	2022-08-24
N206406-003	12083103	2028-05-30	U-2678		2024-09-12
N206406-003	12403095	2028-05-30		Drug product	2025-09-08
N206406-003	9549918	2028-05-30		Drug product	2017-05-02
N206406-003	8664239	2028-08-30	U-1752		2015-08-24
N206406-003	8664239	2028-08-30	U-2677		2015-08-24
N206406-003	8664239	2028-08-30	U-2678		2015-08-24
N206406-003	8685998	2028-08-30	U-1752	Drug product	2015-08-24
N206406-003	8685998	2028-08-30	U-2677	Drug product	2015-08-24
N206406-003	8685998	2028-08-30	U-2678	Drug product	2015-08-24

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206406-002	ENVARSUS XR	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206406-003	ENVARSUS XR	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2015-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206406-001	ENVARSUS XR	EQ 0.75MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2015-07-10	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 77 · 3,063 observed states.

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	N206406-001	10166190	2028-05-30		Drug product	2019-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	10864199	2028-05-30	U-2678		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	10864199	2028-05-30	U-2677		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	11110081	2028-05-30	U-2678		2021-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	11123331	2028-05-30	U-2677		2021-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	11419823	2028-05-30		Drug product	2022-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	12083103	2028-05-30	U-2678		2024-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	12403095	2028-05-30		Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	9549918	2028-05-30		Drug product	2017-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8664239	2028-08-30	U-1752		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8664239	2028-08-30	U-2677		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8664239	2028-08-30	U-2678		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8685998	2028-08-30	U-1752	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8685998	2028-08-30	U-2678	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-001	8685998	2028-08-30	U-2677	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	10166190	2028-05-30		Drug product	2019-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	10864199	2028-05-30	U-2677		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	10864199	2028-05-30	U-2678		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	11110081	2028-05-30	U-2678		2021-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	11123331	2028-05-30	U-2677		2021-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	11419823	2028-05-30		Drug product	2022-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	12083103	2028-05-30	U-2678		2024-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	12403095	2028-05-30		Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	9549918	2028-05-30		Drug product	2017-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8664239	2028-08-30	U-1752		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8664239	2028-08-30	U-2677		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8664239	2028-08-30	U-2678		2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8685998	2028-08-30	U-1752	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8685998	2028-08-30	U-2678	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-002	8685998	2028-08-30	U-2677	Drug product	2015-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	10166190	2028-05-30		Drug product	2019-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	10864199	2028-05-30	U-2677		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	10864199	2028-05-30	U-2678		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	11110081	2028-05-30	U-2678		2021-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	11123331	2028-05-30	U-2677		2021-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	11419823	2028-05-30		Drug product	2022-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	12083103	2028-05-30	U-2678		2024-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	12403095	2028-05-30		Drug product	2025-09-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	9549918	2028-05-30		Drug product	2017-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N206406-003	8664239	2028-08-30	U-1752		2015-08-24	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 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	N206406-001	ODE-94	2022-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206406-002	ODE-94	2022-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206406-003	ODE-94	2022-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206406-001	ODE-94	2022-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206406-002	ODE-94	2022-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206406-003	ODE-94	2022-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206406-001	ODE-94	2022-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206406-002	ODE-94	2022-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206406-003	ODE-94	2022-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206406-001	ODE-94	2022-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206406-002	ODE-94	2022-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206406-003	ODE-94	2022-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206406-001	ODE-94	2022-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206406-002	ODE-94	2022-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206406-003	ODE-94	2022-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206406-001	ODE-94	2022-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206406-002	ODE-94	2022-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206406-003	ODE-94	2022-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206406-001	ODE-94	2022-07-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206406-002	ODE-94	2022-07-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206406-003	ODE-94	2022-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206406-001	ODE-94	2022-07-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206406-002	ODE-94	2022-07-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N206406-003	ODE-94	2022-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206406-001	ODE-94	2022-07-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206406-002	ODE-94	2022-07-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206406-003	ODE-94	2022-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206406-001	ODE-94	2022-07-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206406-002	ODE-94	2022-07-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206406-003	ODE-94	2022-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206406-001	ODE-94	2022-07-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206406-002	ODE-94	2022-07-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206406-003	ODE-94	2022-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206406-001	ODE-94	2022-07-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206406-002	ODE-94	2022-07-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206406-003	ODE-94	2022-07-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206406-001	ODE-94	2022-07-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206406-002	ODE-94	2022-07-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206406-003	ODE-94	2022-07-10	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N206406-001	ODE-94	2022-07-10	`3bdfa0b2c4d7…`

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
Envarsus XR	TACROLIMUS	Veloxis Pharmaceuticals, Inc	de2315b0-6344-43ac-9aea-3e3b68d828e7	2025-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206406 application number: NDA206406 ndc (product): 68992-3040 ndc (product): 68992-3075 ndc (product): 68992-3010

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68992-3010	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3010	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3010	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3010	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3010	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3040	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3040	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3040	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3040	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3040	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3075	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3075	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3075	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3075	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current
68992-3075	Envarsus	Tacrolimus	Veloxis Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78104	SUPPL	2024-04-09
78103	SUPPL	2024-04-09
78095	SUPPL	2024-04-09
75491	SUPPL	2023-09-15
75471	SUPPL	2023-09-15
64626	SUPPL	2020-09-21
64590	SUPPL	2020-09-17
56951	SUPPL	2018-12-21
56897	SUPPL	2018-12-20
56896	SUPPL	2018-12-20
46454	ORIG	2016-12-21
32806	SUPPL	2016-06-24
40547	SUPPL	2016-06-23
40546	SUPPL	2015-08-13
32805	SUPPL	2015-08-13
10569	ORIG	2015-07-14
40545	ORIG	2015-07-13
32804	ORIG	2014-11-04