Orange Book product · Generic (ANDA)
OFLOXACIN
OFLOXACIN
At a glance
Oct 15, 2024
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 15, 2024
1 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
OFLOXACIN
Strength
0.3%
Dosage form
SOLUTION/DROPS
Route
OTIC
TE code
AT
Application
ANDA 216328
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OFLOXACIN
- 1997FLOXIN OTICBrand (NDA)
NDA 020799 · DAIICHI
- 1993OCUFLOXBrand (NDA)
NDA 019921 · ALLERGAN
- 1992FLOXINBrand (NDA)
NDA 020087 · ORTHO MCNEIL PHARM
- 1990FLOXINBrand (NDA)
NDA 019735 · JANSSEN PHARMS
- 2026OFLOXACINGeneric (ANDA)
ANDA 218557 · MICRO LABS
- 2024OFLOXACINGeneric (ANDA)
ANDA 213597 · SOMERSET
- 2024OFLOXACINGeneric (ANDA)
ANDA 217904 · CAPLIN
- 2024OFLOXACINGeneric (ANDA)
ANDA 211524 · AMNEAL
- 2024OFLOXACINGeneric (ANDA)
ANDA 217903 · CAPLIN
- 2022OFLOXACINGeneric (ANDA)
ANDA 215886 · MANKIND PHARMA
- 2022OFLOXACINGeneric (ANDA)
ANDA 216130 · MANKIND PHARMA
- 2022OFLOXACINGeneric (ANDA)
ANDA 215038 · FDC LTD
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.
