Is there a generic for Urea c-13?

The FDA Orange Book does not currently list an approved generic (ANDA) for Urea c-13. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Urea c-13?

BREATHTEK UBT FOR H-PYLORI (NDA 020586, OTSUKA AMERICA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Urea c-13 are approved?

Urea c-13 is approved in the following dosage form: for solution.

FDA Orange Book · active-ingredient family

Urea c-13

Urea c-13 is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:BREATHTEK UBT FOR H-PYLORI · NDA 020586

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for solution

Product	Applicant	Application	TE	Approved
BREATHTEK UBT FOR H-PYLORI×2	OTSUKA AMERICA	NDA 020586	—	May 10, 2001
HELICOSOL	METABOLIC SOLUTIONS	NDA 021092	—	Dec 17, 1999
PYLORI-CHEK BREATH TEST	DXS DEVICES	NDA 020900	—	Feb 04, 1999

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 c-13 — frequently asked questions

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

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