Application 050709

Type: NDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROGRAF	TACROLIMUS	INJECTABLE;INJECTION	EQ 5MG BASE/ML	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050709-001	PROGRAF	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050709-001	AP

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N050709-001	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 2 of 2 · 44 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	N050709-001	PROGRAF	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050709-001	PROGRAF	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050709-001	PROGRAF	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-04-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050709-001	PROGRAF	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-04-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N050709-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050709-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050709-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050709-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050709-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050709-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050709-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050709-001	AP	1	`b8a1b40f171c…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050709-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050709-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050709-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050709-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050709-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050709-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050709-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050709-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050709-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050709-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050709-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050709-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050709-001	AP	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050709-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050709-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050709-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050709-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050709-001	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 71 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	N050709-001	ODE-360	2028-07-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050709-001	ODE-360	2028-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050709-001	ODE-360	2028-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050709-001	ODE-360	2028-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050709-001	ODE-294	2025-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050709-001	ODE-360	2028-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050709-001	ODE-294	2025-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050709-001	ODE-360	2028-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050709-001	ODE-294	2025-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050709-001	ODE-360	2028-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050709-001	ODE-294	2025-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050709-001	ODE-360	2028-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050709-001	ODE-294	2025-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050709-001	ODE-360	2028-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050709-001	ODE-294	2025-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050709-001	ODE-360	2028-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050709-001	ODE-294	2025-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050709-001	ODE-360	2028-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050709-001	ODE-294	2025-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050709-001	ODE-360	2028-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050709-001	ODE-294	2025-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050709-001	ODE-360	2028-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050709-001	ODE-294	2025-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050709-001	ODE-360	2028-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050709-001	ODE-294	2025-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050709-001	ODE-360	2028-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050709-001	ODE-294	2025-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050709-001	ODE-360	2028-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050709-001	ODE-294	2025-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050709-001	ODE-360	2028-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050709-001	ODE-294	2025-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050709-001	ODE-360	2028-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050709-001	ODE-294	2025-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050709-001	ODE-360	2028-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050709-001	ODE-294	2025-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050709-001	ODE-360	2028-07-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N050709-001	ODE-294	2025-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050709-001	ODE-360	2028-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050709-001	ODE-294	2025-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050709-001	ODE-360	2028-07-16	`782e0a99824c…`

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): 050709 application number: NDA050709 ndc (product): 0469-3016

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current
0469-3016	Prograf	Tacrolimus	Astellas Pharma US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72704	SUPPL	2022-11-25
72690	SUPPL	2022-11-23
72689	SUPPL	2022-11-23
71267	SUPPL	2022-06-13
68117	SUPPL	2021-07-19
68101	SUPPL	2021-07-16
65799	SUPPL	2020-12-31
65786	SUPPL	2020-12-31
59031	SUPPL	2019-06-12
56674	SUPPL	2018-12-07
56630	SUPPL	2018-12-04
54354	SUPPL	2018-05-29
54348	SUPPL	2018-05-29
39152	SUPPL	2015-05-21
8062	SUPPL	2015-05-21
18067	SUPPL	2013-09-09
8061	SUPPL	2013-09-09
44517	SUPPL	2012-10-11
42686	SUPPL	2012-10-11
18066	SUPPL	2012-08-15
8060	SUPPL	2012-08-15
39151	SUPPL	2012-07-10
8059	SUPPL	2012-07-09
8058	SUPPL	2012-02-08
39150	SUPPL	2012-02-06
30317	SUPPL	2011-07-19
8057	SUPPL	2011-07-19
18065	SUPPL	2011-07-18
18064	SUPPL	2011-07-18
8055	SUPPL	2009-05-27
18063	SUPPL	2009-05-21
39149	SUPPL	2009-02-20
8056	SUPPL	2009-02-18
39148	SUPPL	2006-05-01
30316	SUPPL	2006-05-01
30315	SUPPL	2006-04-05
8054	SUPPL	2005-12-16
30314	SUPPL	2004-06-23
18062	SUPPL	2004-06-23
42685	ORIG	2003-09-10
39147	SUPPL	2003-05-02
18061	SUPPL	2003-05-02