FDA.reportPublic FDA data

Application 214837

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRABECTEDINTRABECTEDININJECTABLE;INJECTION1MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVDITRABECTEDINApotex Corp.c1d50f5c-4202-27f3-4798-a9708114ddea2026-06-29Warnings, Adverse reactionsName fallback
generic name: TRABECTEDIN
YONDELISTRABECTEDINJanssen Products, LP472bd78e-be17-4b9d-90f4-9482c3aec9ff2026-01-06Warnings, Adverse reactionsName fallback
generic name: TRABECTEDIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72032ORIG2022-09-07