Home Applications 078090 Application 078090
Type ANDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG BASE/4ML (EQ 1MG BASE/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078090-001 GRANISETRON HYDROCHLORIDE GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE / INJECTION AP 2008-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078090-001 AP
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 · 44 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 2022-10-28 04:53 UTC 2022-10 A078090-001 GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE / INJECTION AP 2008-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078090-001 GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE / INJECTION AP 2008-06-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078090-001 GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE / INJECTION AP 2008-06-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078090-001 GRANISETRON HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) INJECTABLE / INJECTION AP 2008-06-30 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Granisetron GRANISETRON HYDROCHLORIDE Fresenius Kabi USA, LLC dddc8714-383f-4bc5-a468-ae89dbc802b4 2022-11-15 Warnings, Adverse reactions Exact identifier ndc (product): 63323-319
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63323-319 Granisetron GRANISETRON HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-319 Granisetron GRANISETRON HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current 63323-319 Granisetron GRANISETRON HYDROCHLORIDE Fresenius Kabi USA, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31329 SUPPL 2014-09-24 39552 SUPPL 2014-09-23