Application 018768

Type: NDA
Sponsor: CORDEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VEPESID	ETOPOSIDE	INJECTABLE;INJECTION	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

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
N018768-001	VEPESID	ETOPOSIDE	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1983-11-10

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018768-001	VEPESID	20MG/ML	INJECTABLE / INJECTION	RLD	1983-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018768-001	VEPESID	20MG/ML	INJECTABLE / INJECTION	RLD	1983-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018768-001	VEPESID	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-10	`e64feba35796…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ETOPOSIDE	ETOPOSIDE	Onesource Specialty Pharma Limited	7bc994df-ee84-4ed7-80fa-737f70918953	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
Etoposide	ETOPOSIDE	Fresenius Kabi USA, LLC	fe870629-104d-4d67-a7c6-f53bc588121e	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
Avopef	ETOPOSIDE	Avyxa Pharma, LLC	acc1e443-ef7b-486f-a638-710a20e81059	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
Etoposide	ETOPOSIDE	BluePoint Laboratories	0dddbe44-b4f4-431f-9011-8a54abbd4cbf	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
VePesid	ETOPOSIDE	Amneal Pharmaceuticals NY LLC	2a40f3ed-4a36-4616-af6c-b616140fd5ee	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: VePesid generic name: ETOPOSIDE
Etoposide	ETOPOSIDE	Meitheal Pharmaceuticals Inc.	50491106-dddd-4efd-bd83-060e7947a244	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
Etoposide	ETOPOSIDE	Accord Healthcare Inc.	4f850eb2-3542-43a0-90e8-bb37fa05cf15	2025-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
Etoposide	ETOPOSIDE	Hikma Pharmaceuticals USA Inc.	e0cd61b9-2375-4e3d-a610-d87dad962468	2024-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
Etoposide	ETOPOSIDE	Hikma Pharmaceuticals USA Inc.	6dfedeff-a807-4405-a482-2f7109ad31c9	2023-09-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
Etoposide	ETOPOSIDE	BluePoint Laboratories	157d4e0f-806d-4011-9dec-97e2449e507b	2018-06-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE
Etoposide	ETOPOSIDE	Mylan Pharmaceuticals Inc.	508a418e-985f-4208-9324-2230655bb5c2	2016-04-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ETOPOSIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11322	SUPPL	2012-08-03
20157	SUPPL	2007-07-06
16036	SUPPL	2002-11-05
20156	SUPPL	1999-04-02