Pytest, Pytest Kit

NDA 20617, held by Avent. Urea, C-14.

As of Nov 14, 2026, NDA 20617 (Pytest, Pytest Kit), held by Avent, was first approved by FDA on May 9, 1997, with 2 approved supplements and 0 published complete response letters.

First approved: May 9, 1997
Review: Priority
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 9, 1997	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Pytest1uCi · capsule;oral	Urea, C-14	DiscontinuedReference drug
Pytest Kit1uCi Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Urea, C-14	DiscontinuedReference drug

All 3 submissions, including labeling and manufacturing supplements


Jan 31, 2014	Supplement 4Manufacturing	Approved	None posted
Mar 17, 2000	Supplement 1Manufacturing · Priority review	Approved	None posted
May 9, 1997	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20617
Drugs@FDA: Overview at FDA
Company: AVENT

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters