Orange Book product · Brand (NDA)
FLECTOR
DICLOFENAC EPOLAMINE
Brand (NDA)NDA 021234RX IBSA
At a glance
Jan 31, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 2007
19 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DICLOFENAC EPOLAMINE
Strength
1.3%
Dosage form
SYSTEM
Route
TOPICAL
TE code
Not listed
Application
NDA 021234
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.
