Orange Book product · Generic (ANDA)
LEVOFLOXACIN
LEVOFLOXACIN
At a glance
Apr 22, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 22, 2020
6 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 205540
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
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
- 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.
