Home Applications 076871 Application 076871
Type ANDA
Sponsor HOSPIRA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE INJECTABLE;INJECTION EQ 20MG BASE/10ML (EQ 2MG BASE/ML) No Yes 002 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE INJECTABLE;INJECTION EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) No Yes 003 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE INJECTABLE;INJECTION EQ 30MG BASE/15ML (EQ 2MG BASE/ML) No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076871-001 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 A076871-002 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 A076871-003 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 of 4 · 132 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 A076871-001 MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A076871-002 MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A076871-003 MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076871-001 MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 A076871-002 MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 A076871-003 MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076871-001 MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076871-002 MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076871-003 MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076871-001 MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076871-002 MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076871-003 MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP RS 2006-04-11 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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.
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61703-343 Mitoxantrone Mitoxantrone Hospira, Inc. ANDA Current 61703-343 Mitoxantrone Mitoxantrone Hospira, Inc. ANDA Current 61703-343 Mitoxantrone Mitoxantrone Hospira, Inc. ANDA Current 61703-343 Mitoxantrone Mitoxantrone Hospira, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8973 ORIG 2006-04-13