Orange Book product · Brand (NDA)
CIPRO
CIPROFLOXACIN HYDROCHLORIDE
At a glance
Oct 22, 1987
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 22, 1987
39 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN HYDROCHLORIDE
Strength
EQ 250MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 019537
Product number
002
Marketing status
RX
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.
- 2009CETRAXALBrand (NDA)
NDA 021918 · LAB SALVAT
- 2005PROQUIN XRBrand (NDA)
NDA 021744 · DEPOMED INC
- 1998CILOXANBrand (NDA)
NDA 020369 · SANDOZ
- 1990CILOXANBrand (NDA)
NDA 019992 · SANDOZ
- 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.
