Application 090596

Type: ANDA
Sponsor: MYLAN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A090596-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17
A090596-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17
A090596-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090596-001	AB
A090596-002	AB
A090596-003	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2010-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090596-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2010-09-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090596-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090596-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090596-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090596-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090596-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090596-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090596-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090596-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090596-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090596-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090596-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090596-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090596-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090596-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090596-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090596-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090596-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090596-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090596-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090596-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090596-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090596-001	AB	1	`1e350fbaab3a…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Safecor Health LLC	393cd10e-133c-4d6b-b024-270eb82edbb3	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596
Tacrolimus	TACROLIMUS	Golden State Medical Supply, Inc.	34ec4989-6933-4237-ae1e-50a0cb90a2fe	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596 ndc (product): 60429-379 ndc (product): 60429-378 ndc (product): 60429-377
Tacrolimus	TACROLIMUS	Mylan Pharmaceuticals Inc.	45af3eda-caaa-4478-9372-95aa65adc9b3	2025-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596 ndc (product): 0378-2045 ndc (product): 0378-2047 ndc (product): 0378-2046
Tacrolimus	TACROLIMUS	MylanInstitutional Inc.	5f742224-618e-4f4c-bdec-7693be99c697	2025-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596 ndc (product): 51079-028 ndc (product): 51079-817 ndc (product): 51079-818
Tacrolimus	TACROLIMUS	Aphena Pharma Solutions - Tennessee, LLC	4caa20af-45a8-4365-9f06-1568afae61b1	2017-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090596 application number: ANDA090596 ndc (product): 43353-317

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2045	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2045	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2045	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2045	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2045	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2045	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2045	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2045	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2046	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2046	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2046	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2046	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2046	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2046	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2046	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2046	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2047	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2047	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2047	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2047	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2047	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2047	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2047	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2047	Tacrolimus	Tacrolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-317	Tacrolimus	Tacrolimus	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-028	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-028	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-028	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-028	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-028	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-028	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-817	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-817	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-817	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-817	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-817	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-817	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-818	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-818	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-818	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-818	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-818	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
51079-818	Tacrolimus	Tacrolimus	Mylan Institutional Inc.	ANDA	Current
55154-4395	Tacrolimus	Tacrolimus	Cardinal Health	ANDA	Current
55154-4395	Tacrolimus	Tacrolimus	Cardinal Health	ANDA	Current
55154-4395	Tacrolimus	Tacrolimus	Cardinal Health	ANDA	Current
60429-377	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-377	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-377	Tacrolimus	Tacrolimus	Golden State Medical Supply	ANDA	Current
60429-377	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-377	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-378	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-378	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-378	Tacrolimus	Tacrolimus	Golden State Medical Supply	ANDA	Current
60429-378	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-378	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-379	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-379	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-379	Tacrolimus	Tacrolimus	Golden State Medical Supply	ANDA	Current
60429-379	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current
60429-379	Tacrolimus	Tacrolimus	Golden State Medical Supply, Inc.	ANDA	Current