Orange Book product · Brand (NDA)
ZYMAR
GATIFLOXACIN
At a glance
Mar 28, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 28, 2003
23 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
GATIFLOXACIN
Strength
0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 021493
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2010ZYMAXIDBrand (NDA)
NDA 022548 · ABBVIE
- 2021GATIFLOXACINGeneric (ANDA)
ANDA 213542 · CAPLIN
- 2018GATIFLOXACINGeneric (ANDA)
ANDA 206446 · RISING
- 2016GATIFLOXACINGeneric (ANDA)
ANDA 204227 · SANDOZ
- 2014GATIFLOXACINGeneric (ANDA)
ANDA 203189 · HIKMA
- 2013GATIFLOXACINGeneric (ANDA)
ANDA 202653 · LUPIN
- 2011GATIFLOXACINGeneric (ANDA)
ANDA 079084 · APOTEX INC
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.
