Is there a generic for Diazoxide?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Diazoxide, referencing the brand PROGLYCEM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Diazoxide?

PROGLYCEM (NDA 017453, TEVA BRANDED PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Diazoxide are approved?

Diazoxide is approved in the following dosage forms: capsule, injectable, suspension.

FDA Orange Book · active-ingredient family

Diazoxide

Diazoxide is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PROGLYCEM · NDA 017453

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, injectable, suspension

Product	Applicant	Application	TE	Approved
PROGLYCEMRLD	TEVA BRANDED PHARM	NDA 017453	AB	Approved Prior to Jan 1, 1982
PROGLYCEM×2	TEVA BRANDED PHARM	NDA 017425	—	Approved Prior to Jan 1, 1982
HYPERSTAT	SCHERING	NDA 016996	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
DIAZOXIDE	NOVITIUM PHARMA	ANDA 210799	AB	Jul 08, 2020
DIAZOXIDE	E5 PHARMA INC	ANDA 211050	AB	Dec 20, 2019
DIAZOXIDE	ABRAXIS PHARM	ANDA 071519	—	Aug 26, 1987

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.

Diazoxide — frequently asked questions

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

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