Is there a generic for Hydroflumethiazide?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Hydroflumethiazide, referencing the brand SALURON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Hydroflumethiazide?

SALURON (NDA 011949, SHIRE LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hydroflumethiazide are approved?

Hydroflumethiazide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Hydroflumethiazide

Hydroflumethiazide is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SALURON · NDA 011949

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
SALURONRLD	SHIRE LLC	NDA 011949	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
HYDROFLUMETHIAZIDE	PAR PHARM	ANDA 088850	—	May 31, 1985
HYDROFLUMETHIAZIDE	WATSON LABS	ANDA 088528	—	Aug 15, 1984
HYDROFLUMETHIAZIDE	WATSON LABS	ANDA 088031	—	Apr 06, 1983
DIUCARDIN	WYETH AYERST	ANDA 083383	—	Approved Prior to Jan 1, 1982

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.

Hydroflumethiazide — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo