Application 081225

Type: ANDA
Sponsor: TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADRUCIL	FLUOROURACIL	INJECTABLE;INJECTION	50MG/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
A081225-001	ADRUCIL	FLUOROURACIL	50MG/ML	INJECTABLE / INJECTION			1991-08-28

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081225-001	ADRUCIL	50MG/ML	INJECTABLE / INJECTION	1991-08-28	`f41ea6bd6efb…`

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUOROURACIL	FLUOROURACIL	Eugia US LLC	199ef964-8a9b-403e-a2ae-759280b3d1d1	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Gland Pharma Limited	572b710e-8e2b-46eb-bd80-648ad769d34d	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Gland Pharma Limited	ea3497db-23b9-4ace-9a6f-b54853d04a82	2025-11-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	ProPharma Distribution	43057fcd-1f87-cc1a-e063-6294a90a8d24	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Encube Ethicals, Inc.	2c631ce7-ea15-4b51-b5bc-4962e3c315cd	2025-10-09	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
FLUOROURACIL	FLUOROURACIL	Encube Ethicals, Inc.	30294dd2-40fb-420d-b838-376343308895	2025-09-09	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	fdf2a165-2ca4-48be-89c1-570e6010b47c	2025-06-11	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Efudex	FLUOROURACIL	Bausch Health US, LLC	35de1c1c-bef5-46c5-b6f8-ea032147411c	2025-04-23		Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Accord Healthcare Inc.	667d4059-de90-4d3f-86c2-c2573def2ecb	2024-10-04	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
FLUOROURACIL	FLUOROURACIL	Dr. Reddy's Labratories Inc.	e137c766-1f7f-0251-90b9-450c3d4d78b9	2024-04-01	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Alembic Pharmaceuticals Limited	b6b0d9e2-c6f0-4523-a33b-b958d32d3a28	2023-11-16	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Alembic Pharmaceuticals Limited	d10f12a2-7b38-4351-93df-1e8444d2a9e4	2023-05-10	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
TOLAK	FLUOROURACIL	HILL DERMACEUTICALS, INC.	59de2709-00b8-4f0a-867c-f0dfeb947192	2022-09-06	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
FLUOROURACIL	FLUOROURACIL	Mayne Pharma Inc.	06475bd8-66d9-4f88-90e4-b367480dab39	2021-11-04	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Mylan Pharmaceuticals Inc.	744737c5-0d96-4214-82ab-6cff016b1ea0	2021-06-30	Warnings, Adverse reactions	Name fallback generic name: FLUOROURACIL

Reported adverse events (FAERS/openFDA)#

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