Orange Book product · Brand (NDA)
IDKIT:HP
CITRIC ACID; UREA C-13
Brand (NDA)NDA 021314RX MERIDIAN BIOSCIENCE
At a glance
Dec 17, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 2002
23 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CITRIC ACID; UREA C-13
Strength
4GM;75MG
Dosage form
FOR SOLUTION, TABLET, FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 021314
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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.
