Orange Book product · Brand (NDA)
CIPRODEX
CIPROFLOXACIN; DEXAMETHASONE
At a glance
Jul 18, 2003
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 18, 2003
23 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CIPROFLOXACIN; DEXAMETHASONE
Strength
0.3%;0.1%
Dosage form
SUSPENSION/DROPS
Route
OTIC
TE code
AB
Application
NDA 021537
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.
- 2026CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 216487 · UPSHER SMITH LABS
- 2024CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 216501 · AMNEAL
- 2023CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 215768 · SENTISS
- 2022CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 210470 · SUN PHARM
- 2020CIPROFLOXACIN AND DEXAMETHASONEGeneric (ANDA)
ANDA 205548 · DR REDDYS
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.
