Home Applications 078260 Application 078260
Type ANDA
Sponsor EPIC PHARMA LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078260-001 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2007-12-31
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A078260-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2007-12-31 a50c72e98297…
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 · 8 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Granisetron Hydrochloride GRANISETRON HYDROCHLORIDE Eugia US LLC 783e9d68-2371-4fd4-8d7a-a5e36f8718d0 2025-04-24 Warnings, Adverse reactions Name fallback brand name: Granisetron Hydrochloride generic name: GRANISETRON HYDROCHLORIDE Granisol GRANISETRON HYDROCHLORIDE Intra-Sana Laboratories 2758eb4d-2fe0-4f74-b3f5-b4903009e97c 2025-03-21 Warnings, Adverse reactions Name fallback generic name: GRANISETRON HYDROCHLORIDE Granisetron Hydrochloride GRANISETRON HYDROCHLORIDE Breckenridge Pharmaceutical, Inc. df4b6775-4337-41e0-815a-b064d98c3fe1 2024-02-29 Warnings, Adverse reactions Name fallback brand name: Granisetron Hydrochloride generic name: GRANISETRON HYDROCHLORIDE Granisetron Hydrochloride GRANISETRON HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. e07862df-f324-4575-a1ef-f7e1cbab4c7a 2024-01-04 Warnings, Adverse reactions Name fallback brand name: Granisetron Hydrochloride generic name: GRANISETRON HYDROCHLORIDE Granisetron Hydrochloride GRANISETRON HYDROCHLORIDE Bionpharma Inc. 50b713d3-7ca8-465a-aefa-65ddbe17b934 2023-12-16 Warnings, Adverse reactions Name fallback brand name: Granisetron Hydrochloride generic name: GRANISETRON HYDROCHLORIDE Granisetron GRANISETRON HYDROCHLORIDE Fresenius Kabi USA, LLC dddc8714-383f-4bc5-a468-ae89dbc802b4 2022-11-15 Warnings, Adverse reactions Name fallback generic name: GRANISETRON HYDROCHLORIDE Granisetron hydrochloride GRANISETRON HYDROCHLORIDE Natco Pharma Limited d2be8de3-04fe-4e92-82b4-98d749b89596 2019-10-25 Warnings, Adverse reactions Name fallback brand name: Granisetron hydrochloride generic name: GRANISETRON HYDROCHLORIDE Granisetron Hydrochloride GRANISETRON HYDROCHLORIDE Mylan Institutional LLC 8d88adba-7f5e-4e97-84b3-6ca8ec98c023 2017-08-31 Warnings, Adverse reactions Name fallback brand name: Granisetron Hydrochloride generic name: GRANISETRON HYDROCHLORIDE