Orange Book product · Brand (NDA)
ORAVERSE
PHENTOLAMINE MESYLATE
Brand (NDA)NDA 022159RX SEPTODONT HOLDING
At a glance
May 09, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 09, 2008
18 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
PHENTOLAMINE MESYLATE
Strength
0.4MG/1.7ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 022159
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.
