Is there a generic for Altretamine?

The FDA Orange Book does not currently list an approved generic (ANDA) for Altretamine. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Altretamine?

HEXALEN (NDA 019926, EISAI INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Altretamine are approved?

Altretamine is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Altretamine

Altretamine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:HEXALEN · NDA 019926

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
HEXALENRLD	EISAI INC	NDA 019926	—	Dec 26, 1990

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.

Altretamine — frequently asked questions

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

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