Is there a generic for Triamterene?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Triamterene, referencing the brand DYRENIUM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Triamterene?

DYRENIUM (NDA 013174, 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 Triamterene are approved?

Triamterene is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Triamterene

Triamterene is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DYRENIUM · NDA 013174

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
DYRENIUMRLD×2	ADVANZ PHARMA	NDA 013174	AB	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
TRIAMTERENE×2	BIOCON GENERICS	ANDA 214768	AB	Jul 06, 2022
TRIAMTERENE×2	AGNITIO	ANDA 211581	AB	Aug 19, 2019

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.

Triamterene — frequently asked questions

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

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