Is there a generic for Oxyphenbutazone?

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

What is the reference-listed drug for Oxyphenbutazone?

TANDEARIL (NDA 012542, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Oxyphenbutazone are approved?

Oxyphenbutazone is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Oxyphenbutazone

Oxyphenbutazone 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:TANDEARIL · NDA 012542

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
TANDEARIL	NOVARTIS	NDA 012542	—	Sep 03, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
OXYPHENBUTAZONE	WATSON LABS	ANDA 088399	—	Sep 17, 1984

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.

Oxyphenbutazone — frequently asked questions

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

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