Is there a generic for Citric acid; urea c-13?

The FDA Orange Book does not currently list an approved generic (ANDA) for Citric acid; urea c-13. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Citric acid; urea c-13?

IDKIT:HP (NDA 021314, MERIDIAN BIOSCIENCE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Citric acid; urea c-13 are approved?

Citric acid; urea c-13 is approved in the following dosage form: for solution, tablet, for solution.

FDA Orange Book · active-ingredient family

Citric acid; urea c-13

Citric acid; urea c-13 is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:IDKIT:HP · NDA 021314

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · for solution, tablet, for solution

Product	Applicant	Application	TE	Approved
IDKIT:HPRLD	MERIDIAN BIOSCIENCE	NDA 021314	—	Dec 17, 2002

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.

Citric acid; 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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