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FDA Orange Book · active-ingredient family

Etoposide

Etoposide is approved as 3 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AVOPEF · NDA 220200

3

Brand (NDA)

16

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, injectable, solution

ProductApplicantApplicationTEApproved
AVOPEFRLDAVYXA HOLDINGSNDA 220200—Feb 13, 2026
VEPESIDRLD×2ONESOURCE SPECIALTYNDA 019557ABDec 30, 1986
VEPESIDRLDCORDEN PHARMANDA 018768—Nov 10, 1983

Generic (ANDA) products (16)

ProductApplicantApplicationTEApproved
ETOPOSIDENATCO PHARMA USAANDA 203507—Nov 20, 2017
ETOPOSIDENATCO PHARMA USAANDA 204927—Oct 31, 2017
ETOPOSIDEMYLANANDA 075635ABSep 19, 2001
ETOPOSIDEFRESENIUS KABI USAANDA 074983APSep 30, 1998
ETOPOSIDEWATSON LABS INCANDA 074968—Jan 09, 1998
ETOPOSIDEPIERRE FABREANDA 074813—Jul 09, 1997
ETOPOSIDEWATSON LABSANDA 074228—Oct 15, 1996
ETOPOSIDEMEITHEALANDA 074529APJul 24, 1996
ETOPOSIDEACCORD HLTHCAREANDA 074513APMar 14, 1996
ETOPOSIDEPHARMACHEMIE BVANDA 074227—Feb 22, 1996
ETOPOSIDEHOSPIRAANDA 074320—Aug 30, 1995
ETOPOSIDEHOSPIRAANDA 074351—Aug 30, 1995
ETOPOSIDEHIKMAANDA 074290APJul 17, 1995
ETOPOSIDETEVA PARENTERALANDA 074510—Jun 29, 1995
TOPOSARTEVA PARENTERALANDA 074166—Feb 27, 1995
ETOPOSIDETEVA PHARMS USAANDA 074284—Feb 10, 1994

Listed patents

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.

Etoposide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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