FDA.reportPublic FDA data

Application 218851

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APREPITANTAPREPITANTEMULSION;INTRAVENOUS32MG/4.4ML (7.2MG/ML)NoNo

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
A218851-001APREPITANTAPREPITANT32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUS2026-03-05

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218851-001APREPITANT32MG/4.4ML (7.2MG/ML)EMULSION / INTRAVENOUS2026-03-05a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
APREPITANTAPREPITANTTorrent Pharmaceuticals Limitedaf9b6086-4bf2-472c-8740-4134eaaebace2026-06-11Warnings, Adverse reactionsName fallback
brand name: APREPITANT
generic name: APREPITANT
CINVANTIAPREPITANTHeron Therapeutics, Inc.4c218d3a-a508-4abc-9ed8-a6e8e191d1b42026-04-01Warnings, Adverse reactionsName fallback
generic name: APREPITANT
APONVIEAPREPITANTHeron Therapeutics, Inc.d1b111eb-659a-496b-a86a-8f0fa370f1472026-04-01Warnings, Adverse reactionsName fallback
generic name: APREPITANT
AprepitantAPREPITANTBluePoint Laboratoriesa78aaa00-a46b-4f9e-a415-2fca9e9a4fb42026-03-27Warnings, Adverse reactionsName fallback
brand name: Aprepitant
generic name: APREPITANT
APREPITANTAPREPITANTGolden State Medical Supply, Inc.377c3ecb-fdec-dde4-e063-6294a90a29bd2026-03-09Warnings, Adverse reactionsName fallback
brand name: APREPITANT
generic name: APREPITANT
AprepitantAPREPITANTGlenmark Pharmaceuticals Inc., USAd72e0e10-4557-41b0-b65d-d395468cad192026-01-28Warnings, Adverse reactionsName fallback
brand name: Aprepitant
generic name: APREPITANT
AprepitantAPREPITANTSandoz Incf58b8944-93ee-4be1-a238-cc0061ddd93a2024-09-09Warnings, Adverse reactionsName fallback
brand name: Aprepitant
generic name: APREPITANT
EMENDAPREPITANTMerck Sharp & Dohme LLC696f9e80-9cae-403b-de9e-078343ce47132024-07-05Warnings, Adverse reactionsName fallback
generic name: APREPITANT