Orange Book product · Brand (NDA)
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
OFLOXACIN
At a glance
Mar 31, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 31, 1992
34 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
OFLOXACIN
Strength
4MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020087
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1997FLOXIN OTICBrand (NDA)
NDA 020799 · DAIICHI
- 1993OCUFLOXBrand (NDA)
NDA 019921 · ALLERGAN
- 1990FLOXINBrand (NDA)
NDA 019735 · JANSSEN PHARMS
- 2026OFLOXACINGeneric (ANDA)
ANDA 218557 · MICRO LABS
- 2024OFLOXACINGeneric (ANDA)
ANDA 216328 · SOMERSET THERAPS LLC
- 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.

