FDA.reportPublic FDA data

Application 074166

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPOSARETOPOSIDEINJECTABLE;INJECTION20MG/MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074166-001TOPOSARETOPOSIDE20MG/MLINJECTABLE / INJECTION1995-02-27

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A074166-001TOPOSAR20MG/MLINJECTABLE / INJECTION1995-02-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074166-001TOPOSAR20MG/MLINJECTABLE / INJECTION1995-02-27cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074166-001TOPOSAR20MG/MLINJECTABLE / INJECTION1995-02-27a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtoposideETOPOSIDEFresenius Kabi USA, LLCfe870629-104d-4d67-a7c6-f53bc588121e2026-07-14Boxed 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
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

Reported adverse events (FAERS/openFDA)#

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