Orange Book product · Brand (NDA)

HELICOSOL

UREA C-13

Brand (NDA)NDA 021092DISCN METABOLIC SOLUTIONS

View UREA C-13 family Open on FDA Orange Book

At a glance

Dec 17, 1999

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Dec 17, 1999
26 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

UREA C-13

Strength

125MG/VIAL

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 021092

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Reference standard (RS)

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

BREATHTEK UBT FOR H-PYLORIBrand (NDA)
NDA 020586 · OTSUKA AMERICA
2001
PYLORI-CHEK BREATH TESTBrand (NDA)
NDA 020900 · DXS DEVICES
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.

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