Orange Book product · Brand (NDA)
IQUIX
LEVOFLOXACIN
At a glance
Mar 01, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 01, 2004
22 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOFLOXACIN
Strength
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 021571
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.
- 2004LEVAQUINBrand (NDA)
NDA 021721 · JANSSEN PHARMS
- 2000QUIXINBrand (NDA)
NDA 021199 · SANTEN
- 1996LEVAQUINBrand (NDA)
NDA 020635 · JANSSEN PHARMS
- 1996LEVAQUINBrand (NDA)
NDA 020634 · JANSSEN PHARMS
- 2024LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 216164 · KNACK
- 2020LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 206908 · GLAND
- 2020LEVOFLOXACINGeneric (ANDA)
ANDA 205540 · GLAND
- 2019LEVOFLOXACINGeneric (ANDA)
ANDA 205600 · MICRO LABS LTD INDIA
- 2019LEVOFLOXACINGeneric (ANDA)
ANDA 204968 · HEC PHARM
- 2018LEVOFLOXACINGeneric (ANDA)
ANDA 205222 · LANNETT CO INC
- 2017LEVOFLOXACINGeneric (ANDA)
ANDA 204899 · PHARMOBEDIENT
- 2017LEVOFLOXACINGeneric (ANDA)
ANDA 205968 · ZYDUS PHARMS
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.
