Orange Book product · Brand (NDA)
ORAVIG
MICONAZOLE
Brand (NDA)NDA 022404RX GALT PHARMS
At a glance
Apr 16, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 16, 2010
16 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
MICONAZOLE
Strength
50MG
Dosage form
TABLET
Route
BUCCAL
TE code
Not listed
Application
NDA 022404
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.
