Home Applications 078564 Application 078564
Type ANDA
Sponsor WOCKHARDT USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 1MG BASE/ML (EQ 1MG BASE/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A078564-001 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE / INJECTION 2008-06-30
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 · 42 observed 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 2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078564-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE / INJECTION 2008-06-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078564-001 GRANISETRON HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) INJECTABLE / INJECTION 2008-06-30 a50c72e98297…
Observed Orange Book normalized TE history# 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 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
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55648-661 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE WOCKHARDT LIMITED ANDA Current 64679-661 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE Wockhardt USA LLC. ANDA Current 64679-661 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE Wockhardt USA LLC. ANDA Current 64679-661 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE Wockhardt USA LLC. ANDA Current