Is there a generic for Etoposide phosphate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Etoposide phosphate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Etoposide phosphate?

ETOPOPHOS PRESERVATIVE FREE (NDA 020457, CHEPLAPHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Etoposide phosphate are approved?

Etoposide phosphate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Etoposide phosphate

Etoposide phosphate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ETOPOPHOS PRESERVATIVE FREE · NDA 020457

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
ETOPOPHOS PRESERVATIVE FREERLD	CHEPLAPHARM	NDA 020457	—	May 17, 1996
ETOPOPHOS PRESERVATIVE FREE×2	BRISTOL MYERS SQUIBB	NDA 020906	—	Feb 27, 1998

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 phosphate — frequently asked questions

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

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