Home Applications 077356 Application 077356
Type ANDA
Sponsor TEVA PHARMS USA 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 No 002 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE INJECTABLE;INJECTION EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) No No 003 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE INJECTABLE;INJECTION EQ 30MG BASE/15ML (EQ 2MG 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077356-001 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 A077356-002 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 A077356-003 MITOXANTRONE HYDROCHLORIDE MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 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 A077356-001 MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A077356-002 MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A077356-003 MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077356-001 MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 A077356-002 MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 A077356-003 MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077356-001 MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077356-002 MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077356-003 MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077356-001 MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077356-002 MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 2006-04-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A077356-003 MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) INJECTABLE / INJECTION AP 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join mitoXANTRONE MITOXANTRONE Meitheal Pharmaceuticals Inc. 1634528a-30c5-4309-acc8-4c0293ae14ae 2025-04-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077356 application number: ANDA077356
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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0703-4680 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4680 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4680 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4680 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4680 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4685 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4685 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4685 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4685 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4685 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4686 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4686 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4686 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4686 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current 0703-4686 mitoXANTRONE mitoXANTRONE Teva Parenteral Medicines, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9038 ORIG 2006-04-12