Application 210929

Type: ANDA
Sponsor: HANGZHOU ZHONGMEI

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	Approval date
A210929-001	TACROLIMUS	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	2023-04-17
A210929-002	TACROLIMUS	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	2023-04-17
A210929-003	TACROLIMUS	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	2023-04-17

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 2 · 69 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	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2023-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL		2023-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL		2023-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2023-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL		2023-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL		2023-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2023-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL		2023-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL		2023-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL		2023-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL		2023-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL		2023-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210929-002	TACROLIMUS	EQ 1MG BASE	CAPSULE / ORAL	AB	2023-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210929-003	TACROLIMUS	EQ 5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210929-001	TACROLIMUS	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2023-04-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210929-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210929-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210929-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210929-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210929-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210929-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210929-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210929-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210929-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210929-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210929-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210929-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210929-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210929-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210929-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210929-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210929-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210929-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210929-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210929-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210929-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210929-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210929-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210929-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210929-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210929-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210929-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210929-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210929-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210929-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210929-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210929-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210929-003	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210929-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210929-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210929-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210929-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210929-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210929-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210929-001	AB	1	`ea1830bbd6c7…`

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
Tacrolimus	TACROLIMUS	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd	759cf905-7406-4d1b-a1a8-10068cb11f04	2025-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210929 application number: ANDA210929