Is there a generic for Urea?

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

What is the reference-listed drug for Urea?

STERILE UREA (NDA 017698, HOSPIRA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Urea are approved?

Urea is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Urea

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

Reference-listed drug:STERILE UREA · NDA 017698

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
STERILE UREA	HOSPIRA	NDA 017698	—	Approved Prior to Jan 1, 1982
UREAPHIL	HOSPIRA	NDA 012154	—	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.

Urea — frequently asked questions

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

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