Orange Book product · Generic (ANDA)
GATIFLOXACIN
GATIFLOXACIN
Generic (ANDA)ANDA 213542TE ATRX CAPLIN
At a glance
Nov 03, 2021
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 03, 2021
4 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
GATIFLOXACIN
Strength
0.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 213542
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GATIFLOXACIN
- 2010ZYMAXIDBrand (NDA)
NDA 022548 · ABBVIE
- 2003ZYMARBrand (NDA)
NDA 021493 · ALLERGAN
- 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.
