Orange Book product · Brand (NDA)
CIPRO
CIPROFLOXACIN
At a glance
Sep 26, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 26, 1997
29 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN
Strength
500MG/5ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 020780
Product number
002
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.
- 2015OTIPRIOBrand (NDA)
NDA 207986 · ALK ABELLO
- 1990CIPROBrand (NDA)
NDA 019847 · BAYER HLTHCARE
- 1990CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019857 · BAYER HLTHCARE
- 1990CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019858 · BAYER PHARMS
- 2014CIPROFLOXACINGeneric (ANDA)
ANDA 200563 · CHARTWELL
- 2009CIPROFLOXACINGeneric (ANDA)
ANDA 076717 · HIKMA FARMACEUTICA
- 2009CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078431 · HIKMA FARMACEUTICA
- 2008CIPROFLOXACINGeneric (ANDA)
ANDA 078062 · BAXTER HLTHCARE CORP
- 2008CIPROFLOXACIN IN DEXTROSE 5%Generic (ANDA)
ANDA 076757 · HIKMA FARMACEUTICA
- 2008CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 077888 · BAXTER HLTHCARE
- 2008CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078024 · BAXTER HLTHCARE CORP
- 2008CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078114 · BEDFORD
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.
