Orange Book product · Brand (NDA)
FLOXIN
OFLOXACIN
At a glance
Dec 28, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 28, 1990
36 yr ago
Today
Pharmaceutical detail
Active ingredient
OFLOXACIN
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 019735
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.
- 1997FLOXIN OTICBrand (NDA)
NDA 020799 · DAIICHI
- 1993OCUFLOXBrand (NDA)
NDA 019921 · ALLERGAN
- 1992FLOXINBrand (NDA)
NDA 020087 · ORTHO MCNEIL PHARM
- 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.
