FDA Orange Book · active-ingredient family
Etoposide
Etoposide: 3 brands, 16 generics; first approved Nov 10, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 16 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
16
Listed patents
0
Presentations
21
Brand (NDA) products
Originator applications
- AVYXA HOLDINGSNDA 22020020262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML (20MG/ML) SOLUTION INTRAVENOUS Rx — 500MG/25ML (20MG/ML) SOLUTION INTRAVENOUS Rx — - VEPESIDRLDONESOURCE SPECIALTYNDA 01955719862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Discontinued — - VEPESIDRLDCORDEN PHARMANDA 0187681983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (16)
Abbreviated applications
- ETOPOSIDENATCO PHARMA USAANDA 2035072017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDENATCO PHARMA USAANDA 2049272017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDERSMYLANANDA 0756352001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB - ETOPOSIDERSFRESENIUS KABI USAANDA 0749831998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - ETOPOSIDEWATSON LABS INCANDA 0749681998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDEPIERRE FABREANDA 0748131997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDEWATSON LABSANDA 0742281996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDEMEITHEALANDA 0745291996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - ETOPOSIDEACCORD HLTHCAREANDA 0745131996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - ETOPOSIDEPHARMACHEMIE BVANDA 0742271996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDEHOSPIRAANDA 0743201995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDEHOSPIRAANDA 0743511995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDEHIKMAANDA 0742901995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Rx AP - ETOPOSIDETEVA PARENTERALANDA 0745101995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - TEVA PARENTERALANDA 0741661995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued — - ETOPOSIDETEVA PHARMS USAANDA 0742841994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/ML INJECTABLE INJECTION Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
43 yr 4 mo ago
Most recent approval
1 mo ago
Approvals span 1983–2026 across 19 FDA applications.
Brand (NDA) 316%
Generic (ANDA) 1684%
Etoposide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
