Is there a generic for Nabilone?

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

What is the reference-listed drug for Nabilone?

CESAMET (NDA 018677, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nabilone are approved?

Nabilone is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Nabilone

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

Reference-listed drug:CESAMET · NDA 018677

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
CESAMETRLD	BAUSCH	NDA 018677	—	Dec 26, 1985

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.

Nabilone — frequently asked questions

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

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