Is there a generic for Nilutamide?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Nilutamide, referencing the brand NILANDRON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Nilutamide?

NILANDRON (NDA 020169, ADVANZ PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nilutamide are approved?

Nilutamide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Nilutamide

Nilutamide is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NILANDRON · NDA 020169

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
NILANDRONRLD×2	ADVANZ PHARMA	NDA 020169	—	Apr 30, 1999

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
NILUTAMIDE	ANI PHARMS	ANDA 207631	—	Jul 15, 2016

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.

Nilutamide — frequently asked questions

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

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