Orange Book product · Brand (NDA)
LEVAQUIN
LEVOFLOXACIN
At a glance
Oct 21, 2004
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 21, 2004
22 yr ago
Today
Pharmaceutical detail
Active ingredient
LEVOFLOXACIN
Strength
250MG/10ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 021721
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.
- 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
- 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.
