Application 012209

Type: NDA
Sponsor: SPECTRUM PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOROURACIL	FLUOROURACIL	INJECTABLE;INJECTION	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	FLUOROURACIL	FLUOROURACIL	INJECTABLE;INJECTION	2.5GM/50ML (50MG/ML)	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012209-001	FLUOROURACIL	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N012209-002	FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2016-07-29

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	RLD	2016-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	RLD	2016-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	RLD	2016-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	RLD	2016-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	RLD	2016-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	RLD	2016-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	RLD	2016-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	RLD	2016-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012209-001	FLUOROURACIL	500MG/10ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012209-002	FLUOROURACIL	2.5GM/50ML (50MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	2016-07-29	`3a93d1ddd44b…`

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUOROURACIL	FLUOROURACIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f0b60247-89ff-42b5-a55b-61980c282749	2026-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FLUOROURACIL generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Sun Pharmaceutical Industries, Inc.	1b2f6145-b338-42ed-88a7-f4da65c59164	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	beb8c6c5-4b6e-4770-b6d4-718e33c7a2ff	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	BluePoint Laboratories	c612b05f-f37d-47fa-9c1e-b2d876dd7093	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	BluePoint Laboratories	cdf07a8b-91ee-424f-8c04-34f53dfb82be	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Sun Pharmaceutical Industries, Inc.	acca0036-f19c-459b-9dfc-9592f1cd588d	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	NORTHSTAR RX LLC	52ef5f41-2312-4b55-aa86-abd5bb28b9d3	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	b4328ae3-f48f-40b1-9719-1c1aced7c734	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	a85ab26a-05ea-498f-8f34-564a925fa9d9	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	21af1777-87f7-4e40-9917-f1677e7ff1a5	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
FLUOROURACIL	FLUOROURACIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b268684b-487f-4716-a2e8-6e6d3e117b14	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FLUOROURACIL generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Meitheal Pharmaceuticals Inc.	de8a3fce-85a9-4a77-a3cd-e50179b93098	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Meitheal Pharmaceuticals Inc.	a0cd6301-c6e0-4b62-8683-39c99913db24	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Fresenius Kabi USA, LLC	c45f5286-a52b-43e5-8a6f-d0312e7da0c8	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Xiromed LLC	19735014-c6fb-0a05-c330-2e9389c71216	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Xiromed LLC	f4b0cae1-a2fc-2991-d663-3b729503cd1c	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Accord Healthcare, Inc.	8eff167f-203a-4a81-b2fc-d8773bc3555e	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
Fluorouracil	FLUOROURACIL	Accord Healthcare, Inc.	66d451fe-2436-494c-80c5-4528c8e34369	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Fluorouracil generic name: FLUOROURACIL
fluorouracil	FLUOROURACIL	Sagent Pharmaceuticals	37e35e8c-5d51-413b-a3a0-b72a18caaf65	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: fluorouracil generic name: FLUOROURACIL
FLUOROURACIL	FLUOROURACIL	Eugia US LLC	697816ce-dc05-4943-b7f0-2f0b125e93b7	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FLUOROURACIL generic name: FLUOROURACIL

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
10798	SUPPL	2016-08-02
311	SUPPL	2016-08-02
20032	SUPPL	1999-01-20