Is there a generic for Troglitazone?

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

What is the reference-listed drug for Troglitazone?

PRELAY (NDA 020719, SANKYO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Troglitazone are approved?

Troglitazone is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Troglitazone

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

Reference-listed drug:PRELAY · NDA 020719

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
PRELAY×3	SANKYO	NDA 020719	—	Jan 29, 1997
REZULIN×3	PFIZER PHARMS	NDA 020720	—	Jan 29, 1997

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.

Troglitazone — frequently asked questions

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

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