Orange Book product · Brand (NDA)
VALSTAR PRESERVATIVE FREE
VALRUBICIN
Brand (NDA)NDA 020892TE AORX ENDO OPERATIONS
At a glance
Sep 25, 1998
Approved
Brand (NDA)
Application
AO
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 1998
28 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
VALRUBICIN
Strength
40MG/ML
Dosage form
SOLUTION
Route
INTRAVESICAL
TE code
AO
Application
NDA 020892
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.
