Application 204096

Type: NDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ASTAGRAF XL	TACROLIMUS	CAPSULE, EXTENDED RELEASE;ORAL	EQ 0.5MG BASE	Yes	No
002	ASTAGRAF XL	TACROLIMUS	CAPSULE, EXTENDED RELEASE;ORAL	EQ 1MG BASE	Yes	No
003	ASTAGRAF XL	TACROLIMUS	CAPSULE, EXTENDED RELEASE;ORAL	EQ 5MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N204096-001	ASTAGRAF XL	TACROLIMUS	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19
N204096-002	ASTAGRAF XL	TACROLIMUS	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19
N204096-003	ASTAGRAF XL	TACROLIMUS	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204096-001	AB
N204096-002	AB
N204096-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-002	ASTAGRAF XL	EQ 1MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-003	ASTAGRAF XL	EQ 5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2013-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204096-001	ASTAGRAF XL	EQ 0.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2013-07-19	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204096-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204096-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204096-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204096-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204096-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204096-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204096-001	6440458	2019-03-25		Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-001	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-001	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-001	8551522	2019-03-25		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-002	6440458	2019-03-25		Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-002	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-002	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-002	8551522	2019-03-25		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-003	6440458	2019-03-25		Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-003	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-003	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204096-003	8551522	2019-03-25		Drug product	2013-11-06	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N204096-001	6440458	2019-03-25		Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-001	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-001	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-001	8551522	2019-03-25		Drug product	2013-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-002	6440458	2019-03-25		Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-002	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-002	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-002	8551522	2019-03-25		Drug product	2013-11-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-003	6440458	2019-03-25		Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-003	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-003	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N204096-003	8551522	2019-03-25		Drug product	2013-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204096-001	6440458	2019-03-25		Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-001	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-001	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-001	8551522	2019-03-25		Drug product	2013-11-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-002	6440458	2019-03-25		Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-002	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-002	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-002	8551522	2019-03-25		Drug product	2013-11-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-003	6440458	2019-03-25		Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-003	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-003	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N204096-003	8551522	2019-03-25		Drug product	2013-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204096-001	6440458	2019-03-25		Drug product	2013-07-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204096-001	6576259	2019-03-25	U-1420	Drug product	2013-07-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204096-001	6884433	2019-03-25	U-1420	Drug product	2013-07-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N204096-001	8551522	2019-03-25		Drug product	2013-11-06	`ea99ee380514…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-001	ODE*	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-002	ODE*	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204096-003	ODE*	2025-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204096-001	ODE*	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-002	ODE*	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204096-003	ODE*	2025-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-001	ODE*	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-002	ODE*	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204096-003	ODE*	2025-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-001	ODE*	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-002	ODE*	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204096-003	ODE*	2025-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-001	ODE*	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-002	ODE*	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204096-003	ODE*	2025-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-001	ODE*	2025-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-002	ODE*	2025-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204096-003	ODE*	2025-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-001	ODE*	2025-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-002	ODE*	2025-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204096-003	ODE*	2025-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-001	ODE*	2025-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-002	ODE*	2025-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204096-003	ODE*	2025-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204096-001	ODE*	2025-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-002	ODE*	2025-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204096-003	ODE*	2025-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-001	ODE*	2025-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-002	ODE*	2025-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204096-003	ODE*	2025-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-001	ODE*	2025-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-002	ODE*	2025-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204096-003	ODE*	2025-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-001	ODE*	2025-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-002	ODE*	2025-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204096-003	ODE*	2025-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204096-001	ODE*	2025-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204096-002	ODE*	2025-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204096-003	ODE*	2025-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204096-001	ODE*	2025-05-24	`5c6f7cd8ea54…`

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
ASTAGRAF XL	TACROLIMUS EXTENDED-RELEASE CAPSULES	Astellas Pharma US, Inc.	550a5cd4-fbf2-4c09-b577-6bde8fcbdf6e	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204096 application number: NDA204096 ndc (product): 0469-0687 ndc (product): 0469-0647 ndc (product): 0469-0677

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
0469-0647	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0647	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0647	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0647	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0647	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0677	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0677	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0677	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0677	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0677	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0687	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0687	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0687	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0687	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current
0469-0687	ASTAGRAF XL	tacrolimus extended-release capsules	Astellas Pharma US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75494	SUPPL	2023-09-15
75493	SUPPL	2023-09-15
75472	SUPPL	2023-09-15
72706	SUPPL	2022-11-25
72692	SUPPL	2022-11-23
72691	SUPPL	2022-11-23
65797	SUPPL	2020-12-31
65796	SUPPL	2020-12-31
65783	SUPPL	2020-12-31
59034	SUPPL	2019-06-12
59033	SUPPL	2019-06-12
59029	SUPPL	2019-06-12
56823	SUPPL	2018-12-20
56598	SUPPL	2018-11-30
32510	SUPPL	2015-12-18
10296	SUPPL	2015-12-18
40354	SUPPL	2015-12-17
19527	SUPPL	2015-12-17
22943	ORIG	2014-12-18
44895	ORIG	2014-11-17
40353	SUPPL	2014-03-04
10295	SUPPL	2014-03-04
10294	SUPPL	2014-02-12
32509	ORIG	2013-07-26
19526	ORIG	2013-07-23