Orange Book product · Generic (ANDA)
LEVOFLOXACIN
LEVOFLOXACIN
At a glance
Jun 20, 2011
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 20, 2011
15 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOFLOXACIN
Strength
EQ 500MG/20ML (EQ 25MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 091644
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of LEVOFLOXACIN
- 2004LEVAQUINBrand (NDA)
NDA 021721 · JANSSEN PHARMS
- 2004IQUIXBrand (NDA)
NDA 021571 · SANTEN
- 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
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.
