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Avopef

etoposide · Injection

Prescription NDA RLD

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Avopef

Generic name

etoposide

Dosage form

Injection

Route

Intravenous

Marketing category

NDA · NDA

Labeler

AVYXA Pharma, LLC

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Etoposide	100 mg/5mL	310248	View
Etoposide	500 mg/25mL	310248	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection

Route of administration

Intravenous

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Topoisomerase Inhibitor [EPC]	EPC	All 11 members
Topoisomerase Inhibitors [MoA]	MoA	All 22 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

220200

Application type

NDA · New Drug Application

Approval date

February 13, 2026

Sponsor

AVYXA HOLDINGS

Products on application

Submissions recorded

Products approved under application 220200.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
220200-001	AVOPEF	SOLUTION		ETOPOSIDE	Prescription	—	RLD RS
220200-002	AVOPEF	SOLUTION		ETOPOSIDE	Prescription	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 220200.
Type	No.	Action	Status	Date	Review
Original application	1	Type 3 - New Dosage Form	Approved	February 13, 2026	Standard

Review documents

0 · Original application · February 24, 2026
0 · Original application · February 18, 2026

Adverse event reports

Source: openFDA FAERS

74,560

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ETOPOSIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
83831-144-05	83831-144	AVYXA Pharma, LLC	1 VIAL in 1 CARTON (83831-144-05) / 5 mL in 1 VIAL	April 1, 2026
83831-145-25	83831-145	AVYXA Pharma, LLC	1 VIAL in 1 CARTON (83831-145-25) / 25 mL in 1 VIAL	September 14, 2026
83831-144	83831-144	AVYXA Pharma, LLC	—	April 1, 2026
83831-145	83831-145	AVYXA Pharma, LLC	—	September 14, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.