FDA.reportPublic FDA data

Application 018768

Type
NDA
Sponsor
CORDEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VEPESIDETOPOSIDEINJECTABLE;INJECTION20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018768-001VEPESIDETOPOSIDE20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1983-11-10

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N018768-001VEPESID20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1983-11-10a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ETOPOSIDEETOPOSIDEOnesource Specialty Pharma Limited7bc994df-ee84-4ed7-80fa-737f709189532026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
EtoposideETOPOSIDEFresenius Kabi USA, LLCfe870629-104d-4d67-a7c6-f53bc588121e2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
AvopefETOPOSIDEAvyxa Pharma, LLCacc1e443-ef7b-486f-a638-710a20e810592026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
EtoposideETOPOSIDEBluePoint Laboratories0dddbe44-b4f4-431f-9011-8a54abbd4cbf2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
VePesidETOPOSIDEAmneal Pharmaceuticals NY LLC2a40f3ed-4a36-4616-af6c-b616140fd5ee2026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: VePesid
generic name: ETOPOSIDE
EtoposideETOPOSIDEMeitheal Pharmaceuticals Inc.50491106-dddd-4efd-bd83-060e7947a2442025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
EtoposideETOPOSIDEAccord Healthcare Inc.4f850eb2-3542-43a0-90e8-bb37fa05cf152025-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
EtoposideETOPOSIDEHikma Pharmaceuticals USA Inc.e0cd61b9-2375-4e3d-a610-d87dad9624682024-09-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
EtoposideETOPOSIDEHikma Pharmaceuticals USA Inc.6dfedeff-a807-4405-a482-2f7109ad31c92023-09-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
EtoposideETOPOSIDEBluePoint Laboratories157d4e0f-806d-4011-9dec-97e2449e507b2018-06-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE
EtoposideETOPOSIDEMylan Pharmaceuticals Inc.508a418e-985f-4208-9324-2230655bb5c22016-04-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ETOPOSIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11322SUPPL2012-08-03
20157SUPPL2007-07-06
16036SUPPL2002-11-05
20156SUPPL1999-04-02