Orange Book product · Brand (NDA)
CIPRO
CIPROFLOXACIN
At a glance
Dec 26, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 26, 1990
36 yr ago
Today
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN
Strength
200MG/20ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 019847
Product number
002
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.
- 2015OTIPRIOBrand (NDA)
NDA 207986 · ALK ABELLO
- 1997CIPROBrand (NDA)
NDA 020780 · 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.
