Application 050708

Type: NDA
Sponsor: ASTELLAS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N050708-001	PROGRAF	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08
N050708-002	PROGRAF	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08
N050708-003	PROGRAF	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050708-001	AB
N050708-002	AB
N050708-003	AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N050708-001	ODE-360	2028-07-16
N050708-002	ODE-360	2028-07-16
N050708-003	ODE-360	2028-07-16

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 4 of 4 · 132 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
2022-10-28 04:53 UTC	2022-10	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050708-001	PROGRAF	EQ 1MG BASE	CAPSULE / ORAL	AB	RLD	1994-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050708-002	PROGRAF	EQ 5MG BASE	CAPSULE / ORAL	AB	RLD, RS	1994-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050708-003	PROGRAF	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD	1998-08-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050708-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050708-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050708-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050708-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050708-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050708-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050708-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050708-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050708-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050708-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050708-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050708-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050708-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050708-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050708-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050708-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050708-001	AB	1	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 213 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N050708-001	ODE-360	2028-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050708-002	ODE-360	2028-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050708-003	ODE-360	2028-07-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050708-001	ODE-360	2028-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050708-002	ODE-360	2028-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050708-003	ODE-360	2028-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050708-001	ODE-360	2028-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050708-002	ODE-360	2028-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050708-003	ODE-360	2028-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050708-001	ODE-360	2028-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-002	ODE-360	2028-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050708-003	ODE-360	2028-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-001	ODE-294	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-001	ODE-360	2028-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-002	ODE-294	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-002	ODE-360	2028-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-003	ODE-294	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050708-003	ODE-360	2028-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050708-001	ODE-294	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-001	ODE-360	2028-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-002	ODE-294	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-002	ODE-360	2028-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-003	ODE-294	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050708-003	ODE-360	2028-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-001	ODE-294	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-001	ODE-360	2028-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-002	ODE-294	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-002	ODE-360	2028-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-003	ODE-294	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050708-003	ODE-360	2028-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-001	ODE-294	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-001	ODE-360	2028-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-002	ODE-294	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-002	ODE-360	2028-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-003	ODE-294	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050708-003	ODE-360	2028-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-001	ODE-294	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-001	ODE-360	2028-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-002	ODE-294	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050708-002	ODE-360	2028-07-16	`03ed91905a0d…`

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
Prograf	TACROLIMUS	Astellas Pharma US, Inc.	7f667de1-9dfa-4bd6-8ba0-15ee2d78873b	2023-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 050708 application number: NDA050708 ndc (product): 0469-0657 ndc (product): 0469-0607 ndc (product): 0469-0617

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 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0469-0607	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0607	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0607	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0607	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0607	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0607	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0607	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0617	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0617	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0617	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0617	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0617	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0617	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0617	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0657	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0657	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0657	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0657	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0657	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0657	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-0657	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
21695-170	Prograf	Tacrolimus	Rebel Distributors Corp	NDA	Current
43353-178	Prograf	Tacrolimus	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75495	SUPPL	2023-09-15
75477	SUPPL	2023-09-15
72703	SUPPL	2022-11-25
72688	SUPPL	2022-11-23
72687	SUPPL	2022-11-23
71266	SUPPL	2022-06-13
68116	SUPPL	2021-07-19
68100	SUPPL	2021-07-16
65798	SUPPL	2020-12-31
65784	SUPPL	2020-12-31
59030	SUPPL	2019-06-12
56673	SUPPL	2018-12-07
56629	SUPPL	2018-12-04
54353	SUPPL	2018-05-29
54347	SUPPL	2018-05-29
30313	SUPPL	2015-05-21
18060	SUPPL	2015-05-21
30312	SUPPL	2013-09-09
18059	SUPPL	2013-09-09
44516	SUPPL	2012-10-11
42684	SUPPL	2012-10-11
18058	SUPPL	2012-08-15
8053	SUPPL	2012-08-15
18057	SUPPL	2012-07-10
30311	SUPPL	2012-07-09
8052	SUPPL	2012-02-08
39146	SUPPL	2012-02-06
30310	SUPPL	2011-07-19
8051	SUPPL	2011-07-19
18056	SUPPL	2011-07-18
18055	SUPPL	2011-07-18
8050	SUPPL	2009-05-27
18053	SUPPL	2009-05-21
18054	SUPPL	2009-02-20
30309	SUPPL	2009-02-18
18052	SUPPL	2006-05-01
8049	SUPPL	2006-05-01
8047	SUPPL	2006-04-05
8048	SUPPL	2005-12-16
39145	SUPPL	2004-06-23
8046	SUPPL	2004-06-23
39142	SUPPL	2004-06-14
42683	ORIG	2003-09-10
39144	SUPPL	2003-05-02
39143	SUPPL	2003-05-02
18051	SUPPL	2003-05-02