Orange Book product · Brand (NDA)
CETRAXAL
CIPROFLOXACIN HYDROCHLORIDE
At a glance
May 01, 2009
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 01, 2009
17 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN HYDROCHLORIDE
Strength
EQ 0.2% BASE
Dosage form
SOLUTION/DROPS
Route
OTIC
TE code
AB
Application
NDA 021918
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2005PROQUIN XRBrand (NDA)
NDA 021744 · DEPOMED INC
- 1998CILOXANBrand (NDA)
NDA 020369 · SANDOZ
- 1990CILOXANBrand (NDA)
NDA 019992 · SANDOZ
- 1987CIPROBrand (NDA)
NDA 019537 · BAYER HLTHCARE
- 2024CIPROFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 217887 · ALEMBIC THERAP
- 2018CIPROFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208921 · YILING
- 2018CIPROFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 204613 · ALTAIRE PHARMS INC
- 2008CIPROFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 076555 · PHARMOBEDIENT
- 2008CIPROFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 077568 · FDC LTD
- 2008CIPROFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 078598 · AMRING PHARMS
- 2007CIPROFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 077859 · AUROBINDO PHARMA
- 2006CIPROFLOXACIN HYDROCHLORIDEGeneric (ANDA)
ANDA 077689 · RISING
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.
