Orange Book product · Generic (ANDA)
GEMIFLOXACIN MESYLATE
GEMIFLOXACIN MESYLATE
Generic (ANDA)ANDA 090466DISCN ORBION PHARMS
At a glance
Jun 15, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 15, 2015
11 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
GEMIFLOXACIN MESYLATE
Strength
EQ 320MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 090466
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GEMIFLOXACIN MESYLATE
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.
