Orange Book product · Brand (NDA)
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
LEVOFLOXACIN
At a glance
Dec 20, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 20, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVOFLOXACIN
Strength
EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020635
Product number
005
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
- 2004IQUIXBrand (NDA)
NDA 021571 · SANTEN
- 2000QUIXINBrand (NDA)
NDA 021199 · SANTEN
- 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.
