Application 203900

Type: ANDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TACROLIMUS	TACROLIMUS	INJECTABLE;INJECTION	EQ 5MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203900-001	TACROLIMUS	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION			2017-08-25

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 · 43 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
2026-09-14 22:38:34	2026-08	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2017-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203900-001	TACROLIMUS	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2017-08-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203900-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203900-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203900-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203900-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203900-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203900-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203900-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203900-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203900-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203900-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203900-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203900-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203900-001	AP	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203900-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203900-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203900-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203900-001	AP	1	`cb3db0bc1861…`

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 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tacrolimus	TACROLIMUS	Strides Pharma Science Limited	ed7d1495-3585-409d-94f1-b3d2469d222c	2025-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	MylanInstitutional Inc.	5f742224-618e-4f4c-bdec-7693be99c697	2025-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	54fcc518-21d9-44a8-9e2c-87ebc2b3e2e6	2025-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Cardinal Health 107, LLC	450c3e32-6d91-4508-b064-49b293e86cec	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Accord Healthcare Inc.	bd447ffa-9196-4c3c-accf-5adf29b84665	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Envarsus XR	TACROLIMUS	Veloxis Pharmaceuticals, Inc	de2315b0-6344-43ac-9aea-3e3b68d828e7	2025-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Quallent Pharmaceuticals Health LLC	23b7b4d7-1431-e9f2-43ba-eabd169dc2dd	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	f21115e2-1d02-4bce-9c13-bf593a52a12f	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Panacea Biotec Limited	bd9fea26-0236-d437-c7df-4b7636210875	2024-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	American Health Packaging	93d03943-0655-44f6-b494-57bd1e336a34	2024-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Accord Healthcare Inc.	80e6817a-9b1e-4f0f-e053-2a91aa0a3d15	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	3dc347e3-9bfd-4910-adb5-24e979208345	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	27154d3a-eec5-4000-a4ff-bfbfe27eb806	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Bryant Ranch Prepack	976f1b69-dd96-4815-b11b-839ce1c45633	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	A-S Medication Solutions	98e0584d-16d2-442b-86ce-e5e65239db0c	2024-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Direct_Rx	10ceb3bc-11cc-13e4-e063-6394a90acce4	2024-03-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
tacrolimus	TACROLIMUS EXTENDED-RELEASE CAPSULES	Chengdu Suncadia Medicine Co., Ltd.	08cf2861-2483-405d-a872-a88a5c235f9a	2024-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: tacrolimus
Tacrolimus	TACROLIMUS	CONCORD BIOTECH LIMITED	823b11cb-d873-4017-a861-d22d2c5a8a49	2023-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Dr. Reddy's Laboratories Limited	61dee012-43af-0e9a-3843-9b9b91e022c4	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS
Tacrolimus	TACROLIMUS	Proficient Rx LP	20d1c12a-bf4b-4467-93a0-ee8b892abea9	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tacrolimus generic name: TACROLIMUS

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49552	ORIG	2017-08-28